Trial Outcomes & Findings for Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder (NCT NCT01354314)
NCT ID: NCT01354314
Last Updated: 2017-06-09
Results Overview
CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
24 Weeks
Results posted on
2017-06-09
Participant Flow
Participant milestones
| Measure |
Paroxetine and Fluconazole
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
11
|
|
Overall Study
Completed (ITT)
|
11
|
11
|
9
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
8
|
6
|
Reasons for withdrawal
| Measure |
Paroxetine and Fluconazole
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Less than 90% Adherence
|
4
|
2
|
6
|
4
|
Baseline Characteristics
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
Baseline characteristics by cohort
| Measure |
Paroxetine and Fluconazole
n=12 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=11 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=11 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.83 Years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
52.00 Years
STANDARD_DEVIATION 6.62 • n=7 Participants
|
51.73 Years
STANDARD_DEVIATION 5.76 • n=5 Participants
|
48.73 Years
STANDARD_DEVIATION 10.23 • n=4 Participants
|
50.56 Years
STANDARD_DEVIATION 7.17 • n=21 Participants
|
|
Age, Customized
25 to 34
|
0 Years
n=5 Participants
|
0 Years
n=7 Participants
|
0 Years
n=5 Participants
|
1 Years
n=4 Participants
|
1 Years
n=21 Participants
|
|
Age, Customized
35 to 44
|
2 Years
n=5 Participants
|
1 Years
n=7 Participants
|
1 Years
n=5 Participants
|
1 Years
n=4 Participants
|
5 Years
n=21 Participants
|
|
Age, Customized
45 to 54
|
8 Years
n=5 Participants
|
7 Years
n=7 Participants
|
7 Years
n=5 Participants
|
5 Years
n=4 Participants
|
27 Years
n=21 Participants
|
|
Age, Customized
55 to 64
|
2 Years
n=5 Participants
|
3 Years
n=7 Participants
|
3 Years
n=5 Participants
|
4 Years
n=4 Participants
|
12 Years
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Sex/Gender, Customized
Transgender (Male to Female)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Education
|
11.83 Years Completed
STANDARD_DEVIATION 2.08 • n=5 Participants
|
12.36 Years Completed
STANDARD_DEVIATION 1.80 • n=7 Participants
|
12.91 Years Completed
STANDARD_DEVIATION 1.87 • n=5 Participants
|
12.36 Years Completed
STANDARD_DEVIATION 2.11 • n=4 Participants
|
12.36 Years Completed
STANDARD_DEVIATION 1.94 • n=21 Participants
|
|
Years Since HIV Diagnosis
|
15.33 Years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
16.36 Years
STANDARD_DEVIATION 7.90 • n=7 Participants
|
15.45 Years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
17.36 Years
STANDARD_DEVIATION 7.93 • n=4 Participants
|
16.11 Years
STANDARD_DEVIATION 7.14 • n=21 Participants
|
|
Absolute CD4 Count
|
516.1 Cells per cubic mm
STANDARD_DEVIATION 244.8 • n=5 Participants
|
637.3 Cells per cubic mm
STANDARD_DEVIATION 241.7 • n=7 Participants
|
555.2 Cells per cubic mm
STANDARD_DEVIATION 282.8 • n=5 Participants
|
510.4 Cells per cubic mm
STANDARD_DEVIATION 235.1 • n=4 Participants
|
553.9 Cells per cubic mm
STANDARD_DEVIATION 248.2 • n=21 Participants
|
|
Plasma HIV Viral Load
Undetectable (<50 copies/mL)
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Plasma HIV Viral Load
Detectable: 50-99 copies/mL
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Plasma HIV Viral Load
Detectable: 100-249 copies/mL
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Plasma HIV Viral Load
Detectable: 250-499 copies/mL
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Hepatitis C Infection Status
Positive History
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Hepatitis C Infection Status
Negative History
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat
|
-30.78 ng/mL
Interval -68.27 to 24.71
|
4.16 ng/mL
Interval -38.76 to 47.95
|
-12.17 ng/mL
Interval -56.98 to 9.81
|
-30.56 ng/mL
Interval -65.78 to 59.94
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol
|
-51.35 ng/mL
Interval -119.66 to 5.95
|
34.11 ng/mL
Interval -4.71 to 51.2
|
-65.00 ng/mL
Interval -69.0 to -60.99
|
-52.37 ng/mL
Interval -87.89 to -7.96
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat
|
6.392 pi*mm^2
Interval -14.214 to 11.674
|
12.235 pi*mm^2
Interval -23.502 to 30.271
|
33.767 pi*mm^2
Interval -10.912 to 35.853
|
-8.747 pi*mm^2
Interval -21.055 to 4.282
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol
|
0.712 pi*mm^2
Interval -17.441 to 10.034
|
0.257 pi*mm^2
Interval -31.676 to 25.563
|
-3.959 pi*mm^2
Interval -22.821 to 14.904
|
-13.160 pi*mm^2
Interval -19.314 to -4.499
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat
|
-17.7 pg/mL
Interval -53.7 to 32.4
|
15.2 pg/mL
Interval -19.1 to 72.3
|
-16.5 pg/mL
Interval -48.5 to -6.1
|
12.0 pg/mL
Interval -53.6 to 21.0
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol
|
-4.3 pg/mL
Interval -62.0 to 60.3
|
33.2 pg/mL
Interval -55.1 to 84.7
|
-5.1 pg/mL
Interval -5.6 to -4.5
|
-18.9 pg/mL
Interval -51.8 to 12.0
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat
|
1.6 ng/mL
Interval -3.2 to 3.5
|
-0.7 ng/mL
Interval -2.4 to 1.1
|
-2.7 ng/mL
Interval -8.1 to 2.6
|
-3.8 ng/mL
Interval -5.1 to 1.4
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF CD163 Between Baseline and Week 24 - Per Protocol
|
-3.2 ng/mL
Interval -6.1 to -0.2
|
-0.7 ng/mL
Interval -2.5 to 3.9
|
-7.5 ng/mL
Interval -9.8 to -5.1
|
-1.8 ng/mL
Interval -3.8 to 0.7
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat
|
0.0890 pg/mL
Interval 0.0285 to 0.1855
|
0.1710 pg/mL
Interval 0.1043 to 0.2733
|
0.2030 pg/mL
Interval -0.027 to 0.217
|
0.1000 pg/mL
Interval -0.0475 to 0.1705
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol
|
0.0560 pg/mL
Interval 0.0233 to 0.118
|
0.1580 pg/mL
Interval -0.0012 to 0.2588
|
0.0985 pg/mL
Interval 0.0358 to 0.1613
|
0.1375 pg/mL
Interval 0.0528 to 0.2223
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=7 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat
|
-0.0080 pg/mL
Interval -0.0275 to 0.0205
|
0.0705 pg/mL
Interval 0.0338 to 0.0975
|
0.0400 pg/mL
Interval 0.029 to 0.128
|
0.0520 pg/mL
Interval 0.0345 to 0.0755
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFH) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=2 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=4 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol
|
-0.0035 pg/mL
Interval -0.0208 to 0.0303
|
0.0645 pg/mL
Interval 0.0133 to 0.0888
|
0.0270 pg/mL
Interval 0.0205 to 0.0335
|
0.0395 pg/mL
Interval 0.013 to 0.0618
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=9 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Trail Making A - Intent to Treat
|
0.045 Z score
Standard Deviation 0.88
|
0.067 Z score
Standard Deviation 0.98
|
0.000 Z score
Standard Deviation 0.77
|
0.09 Z score
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Trail Making A - Per Protocol
|
-0.28 Z score
Standard Deviation 0.96
|
0.17 Z score
Standard Deviation 0.98
|
0.24 Z score
Standard Deviation 0.58
|
0.52 Z score
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=9 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Trail Making B - Intent to Treat
|
0.47 Z score
Standard Deviation 0.98
|
-0.71 Z score
Standard Deviation 0.93
|
0.51 Z score
Standard Deviation 1.03
|
0.020 Z score
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Trail Making B - Per Protocol
|
0.63 Z score
Standard Deviation 0.95
|
-0.83 Z score
Standard Deviation 1.48
|
0.49 Z score
Standard Deviation 0.89
|
0.16 Z score
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat
|
0.23 Z score
Standard Deviation 0.92
|
0.05 Z score
Standard Deviation 1.09
|
0.57 Z score
Standard Deviation 1.05
|
-0.01 Z score
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol
|
0.15 Z score
Standard Deviation 1.10
|
-0.67 Z score
Standard Deviation 0.61
|
0.59 Z score
Standard Deviation 1.23
|
-0.14 Z score
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=8 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat
|
-0.16 Z score
Standard Deviation 1.10
|
-0.11 Z score
Standard Deviation 0.53
|
0.20 Z score
Standard Deviation 0.85
|
0.05 Z score
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol
|
-0.17 Z score
Standard Deviation 1.39
|
0.13 Z score
Standard Deviation 0.61
|
0.41 Z score
Standard Deviation 0.94
|
-0.42 Z score
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=8 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: CalCAP, Choice - Intent to Treat
|
0.152 Z score
Standard Deviation 1.468
|
-0.570 Z score
Standard Deviation 1.348
|
0.871 Z score
Standard Deviation 2.771
|
-1.325 Z score
Standard Deviation 1.779
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=1 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=8 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: CalCAP, Choice - Per Protocol
|
-0.440 Z score
Standard Deviation 1.004
|
-1.17 Z score
Standard Deviation NA
Mean based on only 1 participant
|
1.724 Z score
Standard Deviation 2.711
|
-0.554 Z score
Standard Deviation 1.751
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=6 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=8 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: CalCAP, Sequential - Intent to Treat
|
0.272 Z score
Standard Deviation 0.781
|
-0.025 Z score
Standard Deviation 0.931
|
0.317 Z score
Standard Deviation 1.534
|
-0.530 Z score
Standard Deviation 0.535
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=1 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=8 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: CalCAP, Sequential - Per Protocol
|
0.355 Z score
Standard Deviation 0.886
|
-0.11 Z score
Standard Deviation NA
Mean based on only 1 participant.
|
0.631 Z score
Standard Deviation 1.464
|
-0.394 Z score
Standard Deviation 0.433
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available (no data substitution) at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=9 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Symbol-Digit Test - Intent to Treat
|
0.494 Z score
Standard Deviation 0.828
|
0.175 Z score
Standard Deviation 1.183
|
0.050 Z score
Standard Deviation 0.901
|
-0.175 Z score
Standard Deviation 0.677
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available (no data substitution) at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Symbol-Digit Test - Per Protocol
|
0.354 Z score
Standard Deviation 0.666
|
-0.167 Z score
Standard Deviation 1.010
|
0.275 Z score
Standard Deviation 0.975
|
-0.180 Z score
Standard Deviation 0.903
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=7 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=8 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=8 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Timed Gait - Intent to Treat
|
-0.575 Z score
Standard Deviation 1.038
|
-0.425 Z score
Standard Deviation 1.135
|
0.283 Z score
Standard Deviation 0.869
|
-0.148 Z score
Standard Deviation 1.127
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=5 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: Timed Gait - Per Protocol
|
-0.641 Z score
Standard Deviation 1.141
|
-0.170 Z score
Standard Deviation 1.465
|
0.574 Z score
Standard Deviation 0.833
|
-0.584 Z score
Standard Deviation 1.166
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=10 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=10 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=8 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: NPZ-8 - Intent to Treat
|
0.121 Z score
Standard Deviation 0.538
|
-0.165 Z score
Standard Deviation 0.590
|
0.313 Z score
Standard Deviation 0.628
|
-0.191 Z score
Standard Deviation 0.432
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=7 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Neurocognitive Performance: NPZ-8 - Per Protocol
|
-0.005 Z score
Standard Deviation 0.527
|
-0.298 Z score
Standard Deviation 0.290
|
0.575 Z score
Standard Deviation 0.485
|
-0.199 Z score
Standard Deviation 0.192
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (intent to treat analysis).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=9 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=10 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CES-D Score - Intent to Treat
|
-1.182 units on a scale
Standard Deviation 6.750
|
1.222 units on a scale
Standard Deviation 13.321
|
-1.182 units on a scale
Standard Deviation 2.822
|
2.600 units on a scale
Standard Deviation 8.618
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (per protocol).
Outcome measures
| Measure |
Paroxetine and Fluconazole
n=6 Participants
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=3 Participants
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=8 Participants
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=5 Participants
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Change in CES-D Score - Per Protocol
|
1.667 units on a scale
Standard Deviation 3.327
|
6.000 units on a scale
Standard Deviation 16.093
|
-0.875 units on a scale
Standard Deviation 3.182
|
8.800 units on a scale
Standard Deviation 7.190
|
Adverse Events
Paroxetine and Fluconazole
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Paroxetine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Fluconazole
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paroxetine and Fluconazole
n=12 participants at risk
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=11 participants at risk
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 participants at risk
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=11 participants at risk
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Surgical and medical procedures
Surgery, knee replacement
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Injury, poisoning and procedural complications
Heroin abuse, relapse
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Endocrine disorders
Glucose, non-fasting, high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Surgical and medical procedures
Surgery, neck
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Psychiatric disorders
Depression, acute
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
Other adverse events
| Measure |
Paroxetine and Fluconazole
n=12 participants at risk
Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day
Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
|
Paroxetine
n=11 participants at risk
Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day
Paroxetine: Two 10 MG capsules paroxetine once daily in the evening
|
Fluconazole
n=11 participants at risk
Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day
Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing
|
Placebo
n=11 participants at risk
Placebos in place of fluconazole and paroxetine
Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal cramping or pain
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Immune system disorders
Absolute neutrophil count (ANC), low
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchospasm
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Agitation
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Hepatobiliary disorders
Alanine aminotransferase (ALT), high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Hepatobiliary disorders
Aspartate aminotransferase (AST), high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Hepatobiliary disorders
Alkaline phosphatase, high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Altered taste
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Injury, poisoning and procedural complications
Automobile accident
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain, generalized
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Hepatobiliary disorders
Bilirubin, total, high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 5 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
27.3%
3/11 • Number of events 4 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Metabolism and nutrition disorders
Blood urea nitrogen (BUN), high
|
25.0%
3/12 • Number of events 5 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 3 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
27.3%
3/11 • Number of events 6 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Metabolism and nutrition disorders
Blood urea nitrogen (BUN), low
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Infections and infestations
Chlamydia, new infection/exposure
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Hepatobiliary disorders
Creatinine, blood, high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 3 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Skin and subcutaneous tissue disorders
Cyst, subcutaneous
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Darkening of urine
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • Number of events 5 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Dry mouth
|
25.0%
3/12 • Number of events 3 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Flank pain, unilateral
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Gastroenteritis, foodborne illness
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Endocrine disorders
Glucose, blood, high
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
27.3%
3/11 • Number of events 4 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Glucose, blood, low
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Headache, non-specific
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Nervous system disorders
Headache, post-lumbar puncture
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Hypokalemia
|
8.3%
1/12 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Incontinence, acute nocturnal
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Insomnia
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint pain, generalized
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint pain, hip, unilateral
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint pain, shoulder, unilateral
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Lightheadedness
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Infections and infestations
Lymph node infection, neck
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy, cervical
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 4 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
36.4%
4/11 • Number of events 4 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Renal and urinary disorders
Nephrolithiasis (kidney stone)
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Cardiac disorders
Hypertensive episode
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Nose bleed
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Polyuria
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Renal and urinary disorders
Prostitis
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Psychotropic effects, non-specific
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
36.4%
4/11 • Number of events 4 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Injury, poisoning and procedural complications
Sprain, ankle
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Infections and infestations
Syphilis, new infection/exposure
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Tinnitus, bilateral
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Renal and urinary disorders
Urinary hesitancy
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Eye disorders
Visual changes
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Vivid or disturbing dreams
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
|
General disorders
Weight loss
|
0.00%
0/12 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
0.00%
0/11 • Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place