Trial Outcomes & Findings for Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS) (NCT NCT03990649)
NCT ID: NCT03990649
Last Updated: 2021-07-15
Results Overview
The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative change from Baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and Week 15
Results posted on
2021-07-15
Participant Flow
Participants took part in the study at three investigative sites in United Kingdom (UK) from 23 July 2019 to 28 October 2020.
Participants with a diagnosis of chronic complex regional pain syndrome (CRPS) were enrolled to receive soticlestat or placebo in Part A (Double-blind \[DB\] Treatment Period) and soticlestat in Part B (Open-label \[OL\] Treatment Period). Following completion of the Part A, participants had an option to continue into Part B.
Participant milestones
| Measure |
Double-Blind Treatment Period - Part A: Placebo
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
Open-Label Extension Period - Part B: Soticlestat
Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|---|
|
Part A: DB Treatment Period (15 Weeks)
STARTED
|
9
|
15
|
0
|
|
Part A: DB Treatment Period (15 Weeks)
COMPLETED
|
6
|
12
|
0
|
|
Part A: DB Treatment Period (15 Weeks)
NOT COMPLETED
|
3
|
3
|
0
|
|
Part B: OL Extension Period (14 Weeks)
STARTED
|
0
|
0
|
18
|
|
Part B: OL Extension Period (14 Weeks)
COMPLETED
|
0
|
0
|
14
|
|
Part B: OL Extension Period (14 Weeks)
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Double-Blind Treatment Period - Part A: Placebo
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
Open-Label Extension Period - Part B: Soticlestat
Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|---|
|
Part A: DB Treatment Period (15 Weeks)
Adverse Event
|
0
|
1
|
0
|
|
Part A: DB Treatment Period (15 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
|
Part A: DB Treatment Period (15 Weeks)
Withdrawal by Subject
|
2
|
0
|
0
|
|
Part A: DB Treatment Period (15 Weeks)
Reason not Specified
|
1
|
1
|
0
|
|
Part B: OL Extension Period (14 Weeks)
Adverse Event
|
0
|
0
|
1
|
|
Part B: OL Extension Period (14 Weeks)
Withdrawal by Subject
|
0
|
0
|
2
|
|
Part B: OL Extension Period (14 Weeks)
Reason not Specified
|
0
|
0
|
1
|
Baseline Characteristics
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
Baseline characteristics by cohort
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 10.27 • n=7 Participants
|
41.0 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Numeric Pain Scale (NPS) Score
|
6.33 scores on a scale
n=5 Participants
|
6.33 scores on a scale
n=7 Participants
|
6.33 scores on a scale
n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Physical Function
|
35.83 t-score
STANDARD_DEVIATION 5.607 • n=5 Participants
|
34.65 t-score
STANDARD_DEVIATION 4.743 • n=7 Participants
|
35.09 t-score
STANDARD_DEVIATION 4.998 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Anxiety
|
46.30 t-score
STANDARD_DEVIATION 11.906 • n=5 Participants
|
51.94 t-score
STANDARD_DEVIATION 8.873 • n=7 Participants
|
49.83 t-score
STANDARD_DEVIATION 10.248 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Depression
|
47.31 t-score
STANDARD_DEVIATION 12.523 • n=5 Participants
|
47.27 t-score
STANDARD_DEVIATION 8.868 • n=7 Participants
|
47.28 t-score
STANDARD_DEVIATION 10.120 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Fatigue
|
57.17 t-score
STANDARD_DEVIATION 8.427 • n=5 Participants
|
60.55 t-score
STANDARD_DEVIATION 8.280 • n=7 Participants
|
59.28 t-score
STANDARD_DEVIATION 8.321 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Sleep Disturbance
|
54.63 t-score
STANDARD_DEVIATION 3.854 • n=5 Participants
|
54.99 t-score
STANDARD_DEVIATION 2.390 • n=7 Participants
|
54.86 t-score
STANDARD_DEVIATION 2.945 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Ability to Participate in Social Roles and Activities
|
40.03 t-score
STANDARD_DEVIATION 6.205 • n=5 Participants
|
39.11 t-score
STANDARD_DEVIATION 4.723 • n=7 Participants
|
39.45 t-score
STANDARD_DEVIATION 5.213 • n=5 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score
Pain Interference
|
66.37 t-score
STANDARD_DEVIATION 6.710 • n=5 Participants
|
64.22 t-score
STANDARD_DEVIATION 8.039 • n=7 Participants
|
65.03 t-score
STANDARD_DEVIATION 7.492 • n=5 Participants
|
|
CRPS Severity Score (CSS) Total Score
|
12.7 scores on a scale
STANDARD_DEVIATION 1.73 • n=5 Participants
|
12.9 scores on a scale
STANDARD_DEVIATION 1.87 • n=7 Participants
|
12.8 scores on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses.
The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=7 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=12 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A
|
-0.74 scores on scale
Standard Deviation 1.614
|
-1.05 scores on scale
Standard Deviation 1.310
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses.
The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative percent change from Baseline indicated improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=7 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=12 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A
|
-12.20 percent change
Standard Deviation 29.108
|
-18.35 percent change
Standard Deviation 23.699
|
SECONDARY outcome
Timeframe: Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure.
Response was defined as ≥ 30% improvement on the 24-hour pain intensity as assessed by the NPS score. The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS during Part A. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Percentage of Participants Considered Responders at the End of Part A
|
22.2 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Number analyzed are the number of participants with data available for analyses in the given category (domain).
PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Physical Function
|
1.53 t-score
Standard Deviation 2.207
|
2.39 t-score
Standard Deviation 4.042
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Anxiety
|
3.29 t-score
Standard Deviation 10.348
|
-1.99 t-score
Standard Deviation 9.567
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Depression
|
1.15 t-score
Standard Deviation 10.011
|
-0.78 t-score
Standard Deviation 6.902
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Fatigue
|
0.45 t-score
Standard Deviation 12.126
|
-3.66 t-score
Standard Deviation 10.456
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Sleep Disturbance
|
2.13 t-score
Standard Deviation 5.110
|
2.55 t-score
Standard Deviation 1.927
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Ability to Participate in Social Roles
|
1.66 t-score
Standard Deviation 6.051
|
2.74 t-score
Standard Deviation 5.147
|
|
Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Pain Interference
|
-1.53 t-score
Standard Deviation 6.257
|
-0.38 t-score
Standard Deviation 7.597
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Number analyzed are the number of participants with data available for analyses in the given category (domain).
PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Physical Function
|
4.27 percent change
Standard Deviation 6.197
|
8.00 percent change
Standard Deviation 14.106
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Anxiety
|
9.35 percent change
Standard Deviation 24.153
|
-2.43 percent change
Standard Deviation 16.584
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Depression
|
4.51 percent change
Standard Deviation 21.864
|
0.04 percent change
Standard Deviation 13.494
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Fatigue
|
2.42 percent change
Standard Deviation 22.902
|
-4.62 percent change
Standard Deviation 16.045
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Sleep Disturbance
|
4.46 percent change
Standard Deviation 9.611
|
4.75 percent change
Standard Deviation 3.600
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Ability to Participate in Social Roles
|
4.39 percent change
Standard Deviation 15.195
|
7.42 percent change
Standard Deviation 13.796
|
|
Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A
Pain Interference
|
-1.88 percent change
Standard Deviation 9.149
|
0.82 percent change
Standard Deviation 15.571
|
SECONDARY outcome
Timeframe: Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure.
The PGIC is a 7-point Likert scale to address the following question: Since beginning treatment at this clinic would you describe any changes (if any) in activity, limitations, symptoms, emotions and overall quality of life related to your painful condition compared to before treatment? Participants select from scale range of 1-7: very much improved (1); much improved (2); minimally improved (3); no change (4); minimally worse (5); much worse (6); very much worse (7). Only categories with at least 1 participant were reported.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A
Much Improved
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A
Minimally Improved
|
11.1 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A
No Change
|
22.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A
Minimally Worse
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A
Missing
|
22.2 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses.
Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=6 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=13 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A
|
-2.2 scores on scale
Standard Deviation 2.48
|
-3.1 scores on scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses.
Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative percent change from Baseline indicates improvement.
Outcome measures
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=6 Participants
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=13 Participants
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|
|
Percent Change From Baseline in CSS at the End of Part A
|
-16.1 percent change
Standard Deviation 18.89
|
-23.8 percent change
Standard Deviation 26.29
|
Adverse Events
Double-Blind Treatment Period - Part A: Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Double-Blind Treatment Period - Part A: Soticlestat
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Open-Label Extension Period - Part B: Soticlestat
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 participants at risk
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 participants at risk
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
Open-Label Extension Period - Part B: Soticlestat
n=18 participants at risk
Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Double-Blind Treatment Period - Part A: Placebo
n=9 participants at risk
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
|
Double-Blind Treatment Period - Part A: Soticlestat
n=15 participants at risk
Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
Open-Label Extension Period - Part B: Soticlestat
n=18 participants at risk
Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
3/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
26.7%
4/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.8%
5/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depressed mood
|
22.2%
2/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER