Trial Outcomes & Findings for A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency (NCT NCT01700387)
NCT ID: NCT01700387
Last Updated: 2020-08-18
Results Overview
Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Collected on Visit 2 (Day 29) through Visit 6 (Day 365)
Results posted on
2020-08-18
Participant Flow
Participant milestones
| Measure |
OnabotulinumtoxinA + Topiramate
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
OnabotulinumtoxinA + Topiramate
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
Baseline characteristics by cohort
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.84 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
39.51 years
STANDARD_DEVIATION 6.99 • n=7 Participants
|
40.18 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected on Visit 2 (Day 29) through Visit 6 (Day 365)Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Subject Attrition Post Randomization
Consent Withdrawn
|
1 participants
|
2 participants
|
|
Subject Attrition Post Randomization
Withdrawn Due to Adverse Event
|
1 participants
|
1 participants
|
|
Subject Attrition Post Randomization
Lost to Follow Up
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Subject Global Impression of Change (SGIC)
Visit 3
|
5.38 units on a scale
Standard Deviation 1.19
|
5.30 units on a scale
Standard Deviation 1.25
|
|
Subject Global Impression of Change (SGIC)
Visit 5
|
6.66 units on a scale
Standard Deviation 0.52
|
6.17 units on a scale
Standard Deviation 1.17
|
|
Subject Global Impression of Change (SGIC)
Visit 6
|
7.00 units on a scale
Standard Deviation 0.00
|
6.00 units on a scale
Standard Deviation 1.26
|
|
Subject Global Impression of Change (SGIC)
Visit 4
|
6.33 units on a scale
Standard Deviation 0.82
|
5.77 units on a scale
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Physician Global Impression of Change (PGIC)
Visit 3
|
5.25 units on a scale
Standard Deviation 1.16
|
5.30 units on a scale
Standard Deviation 1.25
|
|
Physician Global Impression of Change (PGIC)
Visit 4
|
5.40 units on a scale
Standard Deviation 1.34
|
5.89 units on a scale
Standard Deviation 0.93
|
|
Physician Global Impression of Change (PGIC)
Visit 5
|
6.67 units on a scale
Standard Deviation 0.52
|
5.83 units on a scale
Standard Deviation 1.94
|
|
Physician Global Impression of Change (PGIC)
Visit 6
|
6.83 units on a scale
Standard Deviation 0.41
|
5.83 units on a scale
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: Baseline, Visit 3 (Day 113) through Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency. Raw COWAT scores have a lower bound of 0 with no upper bound. Higher scores indicate better verbal fluency. COWAT score percent change from baseline will be reported. Positive change scores represent better verbal fluency compared to baseline.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Subject's Controlled Oral Word Association Test (COWAT) Score Percent Change Compared From Baseline to Visits 3-6
Visit 5
|
-12.63 percentage of change from baseline score
Standard Deviation 12.24
|
1.48 percentage of change from baseline score
Standard Deviation 17.32
|
|
Subject's Controlled Oral Word Association Test (COWAT) Score Percent Change Compared From Baseline to Visits 3-6
Visit 3
|
-17.06 percentage of change from baseline score
Standard Deviation 9.47
|
-3.50 percentage of change from baseline score
Standard Deviation 23.71
|
|
Subject's Controlled Oral Word Association Test (COWAT) Score Percent Change Compared From Baseline to Visits 3-6
Visit 4
|
-17.93 percentage of change from baseline score
Standard Deviation 10.63
|
-8.93 percentage of change from baseline score
Standard Deviation 22.95
|
|
Subject's Controlled Oral Word Association Test (COWAT) Score Percent Change Compared From Baseline to Visits 3-6
Visit 6
|
-5.05 percentage of change from baseline score
Standard Deviation 20.99
|
-4.99 percentage of change from baseline score
Standard Deviation 19.04
|
SECONDARY outcome
Timeframe: Baseline and Months 1-12Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
Number of Headache Days reported in 30-day Baseline Period and Treatment Period Months 1-12
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Number of Headache Days
Month 7
|
12.64 Headache days
Standard Deviation 6.39
|
12.54 Headache days
Standard Deviation 9.23
|
|
Number of Headache Days
Month 8
|
12.36 Headache days
Standard Deviation 5.16
|
11.5 Headache days
Standard Deviation 7.26
|
|
Number of Headache Days
Baseline
|
22.95 Headache days
Standard Deviation 4.39
|
23.77 Headache days
Standard Deviation 4.64
|
|
Number of Headache Days
Month 1
|
18.41 Headache days
Standard Deviation 5.96
|
21.67 Headache days
Standard Deviation 4.28
|
|
Number of Headache Days
Month 2
|
16.50 Headache days
Standard Deviation 7.61
|
17.54 Headache days
Standard Deviation 6.81
|
|
Number of Headache Days
Month 3
|
16.83 Headache days
Standard Deviation 7.12
|
18.37 Headache days
Standard Deviation 7.76
|
|
Number of Headache Days
Month 4
|
15.74 Headache days
Standard Deviation 8.09
|
14.39 Headache days
Standard Deviation 10.05
|
|
Number of Headache Days
Month 5
|
11.34 Headache days
Standard Deviation 7.17
|
13.47 Headache days
Standard Deviation 8.95
|
|
Number of Headache Days
Month 6
|
15.18 Headache days
Standard Deviation 6.07
|
16.58 Headache days
Standard Deviation 7.68
|
|
Number of Headache Days
Month 9
|
12.02 Headache days
Standard Deviation 5.6
|
9.96 Headache days
Standard Deviation 5.71
|
|
Number of Headache Days
Month 10
|
6.93 Headache days
Standard Deviation 4.59
|
8.02 Headache days
Standard Deviation 1.06
|
|
Number of Headache Days
Month 11
|
8.36 Headache days
Standard Deviation 6.5
|
8.51 Headache days
Standard Deviation 6.09
|
|
Number of Headache Days
Month 12
|
7.51 Headache days
Standard Deviation 5.04
|
8.06 Headache days
Standard Deviation 5.34
|
SECONDARY outcome
Timeframe: Collected on Visit 2 (Day 29), 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Headache Impact Test (HIT-6) is a tool used to measure the impact headaches have on an individual's ability to function on the job, at school, at home and in social situations. The HIT-6 score range is from 36 to 78 with higher scores indicating greater impact (worse outcome).
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life
Visit 3
|
61.89 units on a scale
Standard Deviation 6.92
|
59.9 units on a scale
Standard Deviation 7.77
|
|
Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life
Visit 2
|
66.40 units on a scale
Standard Deviation 5.19
|
66.50 units on a scale
Standard Deviation 3.84
|
|
Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life
Visit 4
|
54.5 units on a scale
Standard Deviation 5.39
|
60.44 units on a scale
Standard Deviation 8.19
|
|
Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life
Visit 5
|
52.83 units on a scale
Standard Deviation 7.44
|
58.71 units on a scale
Standard Deviation 7.85
|
|
Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life
Visit 6
|
52.57 units on a scale
Standard Deviation 7.20
|
54.17 units on a scale
Standard Deviation 9.81
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Mental Efficiency Workload Test (MEWT) is a cognitive functioning scale with four sub-scales (Simple Reaction Time, Running Memory Continuous Performance Task, Matching to Sample, and Mathematical Processing). Each sub-scale has a minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. MEWT sub-scale score percent change from baseline will be reported. Positive change scores represent better cognitive functioning compared to baseline.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
MEWT Simple Reaction Time Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 4
|
-3.20 percentage of change from baseline score
Standard Deviation 17.15
|
4.76 percentage of change from baseline score
Standard Deviation 8.44
|
|
MEWT Simple Reaction Time Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 5
|
-3.87 percentage of change from baseline score
Standard Deviation 25.48
|
-4.17 percentage of change from baseline score
Standard Deviation 10.05
|
|
MEWT Simple Reaction Time Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 6
|
-3.16 percentage of change from baseline score
Standard Deviation 24.15
|
2.31 percentage of change from baseline score
Standard Deviation 18.86
|
|
MEWT Simple Reaction Time Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 3
|
-8.90 percentage of change from baseline score
Standard Deviation 18.62
|
14.22 percentage of change from baseline score
Standard Deviation 30.32
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Mental Efficiency Workload Test (MEWT) is a cognitive functioning scale with four sub-scales (Simple Reaction Time, Running Memory Continuous Performance Task, Matching to Sample, and Mathematical Processing). Each sub-scale has a minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. MEWT sub-scale score percent change from baseline will be reported. Positive change scores represent better cognitive functioning compared to baseline.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
MEWT Running Memory Continuous Performance Task Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 6
|
-6.99 percentage of change from baseline score
Standard Deviation 43.50
|
2.2 percentage of change from baseline score
Standard Deviation 31.91
|
|
MEWT Running Memory Continuous Performance Task Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 3
|
-15.66 percentage of change from baseline score
Standard Deviation 38.87
|
1.13 percentage of change from baseline score
Standard Deviation 24.70
|
|
MEWT Running Memory Continuous Performance Task Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 4
|
-1.20 percentage of change from baseline score
Standard Deviation 41.31
|
4.39 percentage of change from baseline score
Standard Deviation 16.55
|
|
MEWT Running Memory Continuous Performance Task Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 5
|
-3.96 percentage of change from baseline score
Standard Deviation 43.64
|
18.81 percentage of change from baseline score
Standard Deviation 28.45
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Mental Efficiency Workload Test (MEWT) is a cognitive functioning scale with four sub-scales (Simple Reaction Time, Running Memory Continuous Performance Task, Matching to Sample, and Mathematical Processing). Each sub-scale has a minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. MEWT sub-scale score percent change from baseline will be reported. Positive change scores represent better cognitive functioning compared to baseline.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
MEWT Matching to Sample Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 3
|
19.06 percentage of change from baseline score
Standard Deviation 44.13
|
21.74 percentage of change from baseline score
Standard Deviation 27.86
|
|
MEWT Matching to Sample Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 4
|
15.04 percentage of change from baseline score
Standard Deviation 47.59
|
8.59 percentage of change from baseline score
Standard Deviation 25.34
|
|
MEWT Matching to Sample Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 5
|
18.49 percentage of change from baseline score
Standard Deviation 45.11
|
12.72 percentage of change from baseline score
Standard Deviation 23.34
|
|
MEWT Matching to Sample Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 6
|
40.86 percentage of change from baseline score
Standard Deviation 42.88
|
24.75 percentage of change from baseline score
Standard Deviation 49.32
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Mental Efficiency Workload Test (MEWT) is a cognitive functioning scale with four sub-scales (Simple Reaction Time, Running Memory Continuous Performance Task, Matching to Sample, and Mathematical Processing). Each sub-scale has a minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. MEWT sub-scale score percent change from baseline will be reported. Positive change scores represent better cognitive functioning compared to baseline.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=8 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
MEWT Mathematical Processing Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 3
|
-11.23 percentage of change from baseline score
Standard Deviation 22.61
|
17.74 percentage of change from baseline score
Standard Deviation 50.54
|
|
MEWT Mathematical Processing Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 4
|
-22.90 percentage of change from baseline score
Standard Deviation 16.48
|
16.43 percentage of change from baseline score
Standard Deviation 35.88
|
|
MEWT Mathematical Processing Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 5
|
-23.81 percentage of change from baseline score
Standard Deviation 16.26
|
28.61 percentage of change from baseline score
Standard Deviation 48.44
|
|
MEWT Mathematical Processing Sub-test Score Percent Change Compared From Baseline to Visits 3-6
Visit 6
|
1.52 percentage of change from baseline score
Standard Deviation 8.91
|
29.44 percentage of change from baseline score
Standard Deviation 50.47
|
SECONDARY outcome
Timeframe: Collected on Visit 2 (Day 29), 3 (Day 113), Visit 4 (Day 197), and Visit 5 (281)Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
Subject estimation of compliance with daily study drug during the study period. Compliance ranges from 0% to 100% with higher percentages indicating greater compliance with study drug.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=9 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Subject Estimation of Compliance With Daily Study Drug
Visit 5
|
98.69 percentage of compliance
Standard Deviation 1.61
|
99.63 percentage of compliance
Standard Deviation 2.35
|
|
Subject Estimation of Compliance With Daily Study Drug
Visit 2
|
100 percentage of compliance
Standard Deviation 0
|
99.73 percentage of compliance
Standard Deviation 0.58
|
|
Subject Estimation of Compliance With Daily Study Drug
Visit 3
|
99.84 percentage of compliance
Standard Deviation 0.46
|
99.73 percentage of compliance
Standard Deviation 0.56
|
|
Subject Estimation of Compliance With Daily Study Drug
Visit 4
|
99.55 percentage of compliance
Standard Deviation 1.10
|
97.65 percentage of compliance
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: 13 Months (Visit 1 to Visit 6)Population: All consenting participants.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Number of Non-Serious Adverse Events Between Groups
|
8.60 Adverse Events
Standard Deviation 8.93
|
4.60 Adverse Events
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Baseline, Months: 3, 6, 9 and 12Population: Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.
The Migraine-Specific Quality of Life Questionnaire (MSQ) is a scale that measures the impact of migraine across three aspects: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Possible scores on each sub-scale range from a 0 to 100 scale such that higher scores indicate better quality of life.
Outcome measures
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 Participants
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Restrictive - Baseline
|
32.14 score on a scale
Standard Deviation 16.62
|
29.71 score on a scale
Standard Deviation 14.77
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Preventive - Month 9
|
88.33 score on a scale
Standard Deviation 8.16
|
72.86 score on a scale
Standard Deviation 26.28
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Emotional Function - Month 6
|
88.89 score on a scale
Standard Deviation 6.89
|
56.30 score on a scale
Standard Deviation 32.51
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Emotional Function - Month 9
|
92.22 score on a scale
Standard Deviation 16.01
|
70.48 score on a scale
Standard Deviation 29.02
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Restrictive - Month 3
|
56.51 score on a scale
Standard Deviation 25.18
|
56.29 score on a scale
Standard Deviation 25.16
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Restrictive - Month 6
|
77.14 score on a scale
Standard Deviation 10.22
|
59.37 score on a scale
Standard Deviation 21.94
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Restrictive - Month 9
|
79.52 score on a scale
Standard Deviation 13.21
|
60.41 score on a scale
Standard Deviation 25.52
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Restrictive - Month 12
|
81.90 score on a scale
Standard Deviation 12.21
|
72.38 score on a scale
Standard Deviation 24.36
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Preventive - Baseline
|
56.50 score on a scale
Standard Deviation 22.61
|
46.50 score on a scale
Standard Deviation 24.39
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Preventive - Month 3
|
72.78 score on a scale
Standard Deviation 26.82
|
65.00 score on a scale
Standard Deviation 28.28
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Preventive - Month 6
|
90.00 score on a scale
Standard Deviation 8.37
|
72.22 score on a scale
Standard Deviation 26.94
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Role Function-Preventive - Month 12
|
96.67 score on a scale
Standard Deviation 2.58
|
80.83 score on a scale
Standard Deviation 24.98
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Emotional Function - Baseline
|
39.33 score on a scale
Standard Deviation 30.70
|
22.67 score on a scale
Standard Deviation 22.04
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Emotional Function - Month 3
|
57.78 score on a scale
Standard Deviation 36.67
|
56.67 score on a scale
Standard Deviation 33.15
|
|
Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life
Emotional Function - Month 12
|
95.56 score on a scale
Standard Deviation 8.07
|
78.89 score on a scale
Standard Deviation 28.10
|
Adverse Events
OnabotulinumtoxinA + Topiramate
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
OnabotulinumtoxinA + Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 participants at risk
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 participants at risk
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Rectal Proplapse
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal Failure
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Septic Shock
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
OnabotulinumtoxinA + Topiramate
n=10 participants at risk
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:
Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
OnabotulinumtoxinA + Placebo
n=10 participants at risk
Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:
Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid
onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
|
|---|---|---|
|
Nervous system disorders
Decreased Cognition
|
50.0%
5/10 • Number of events 6
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 4
|
30.0%
3/10 • Number of events 3
|
|
General disorders
Vertigo
|
20.0%
2/10 • Number of events 3
|
40.0%
4/10 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection
|
10.0%
1/10 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
Additional Information
Dr. Roger Cady
Clinvest/A Division of Banyan Group Inc.
Phone: 417-883-7889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place