Trial · NCT03990649
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
NCT03990649, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2021-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS). Trials, record NCT03990649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03990649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
- NCT number
- NCT03990649
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Complex Regional Pain Syndrome
- Interventions
- Soticlestat, Placebo
- First posted
- 2019-06-19
- Last updated
- 2026-09-14
- Results first posted
- 2021-07-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Baseline and Week 15 | 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. |
| Secondary | Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Baseline and Week 15 | 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. |
| Secondary | Percentage of Participants Considered Responders at the End of Part A | Week 15 | 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. |
| Secondary | Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Baseline and Week 15 | 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. |
| Secondary | Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Baseline and Week 15 | 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. |
| Secondary | Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A | Week 15 | 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. |
| Secondary | Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A | Baseline and Week 15 | 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. |
| Secondary | Percent Change From Baseline in CSS at the End of Part A | Baseline and Week 15 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Baseline and Week 15 | 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. | scores on scale | MEAN |
| SECONDARY | Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Baseline and Week 15 | 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. | percent change | MEAN |
| SECONDARY | Percentage of Participants Considered Responders at the End of Part A | Week 15 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Baseline and Week 15 | 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). | t-score | MEAN |
| SECONDARY | Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Baseline and Week 15 | 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). | percent change | MEAN |
| SECONDARY | Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A | Week 15 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A | Baseline and Week 15 | 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. | scores on scale | MEAN |
| SECONDARY | Percent Change From Baseline in CSS at the End of Part A | Baseline and Week 15 | 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. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Double-Blind Treatment Period - Part A: Placebo | -0.74 | Standard Deviation 1.614 | scores on scale | |
| Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Double-Blind Treatment Period - Part A: Soticlestat | -1.05 | Standard Deviation 1.310 | scores on scale | |
| Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Double-Blind Treatment Period - Part A: Placebo | -12.20 | Standard Deviation 29.108 | percent change | |
| Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | Double-Blind Treatment Period - Part A: Soticlestat | -18.35 | Standard Deviation 23.699 | percent change | |
| Percentage of Participants Considered Responders at the End of Part A | Double-Blind Treatment Period - Part A: Placebo | 22.2 | percentage of participants | ||
| Percentage of Participants Considered Responders at the End of Part A | Double-Blind Treatment Period - Part A: Soticlestat | 26.7 | percentage of participants | ||
| Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Double-Blind Treatment Period - Part A: Placebo | Physical Function | 1.53 | Standard Deviation 2.207 | t-score |
| Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Double-Blind Treatment Period - Part A: Soticlestat | Physical Function | 2.39 | Standard Deviation 4.042 | t-score |
| Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Double-Blind Treatment Period - Part A: Placebo | Anxiety | 3.29 | Standard Deviation 10.348 | t-score |
| Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | Double-Blind Treatment Period - Part A: Soticlestat | Anxiety | -1.99 | Standard Deviation 9.567 | t-score |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: DB Treatment Period (15 Weeks) | STARTED | Double-Blind Treatment Period - Part A: Placebo | 9 | |
| Part A: DB Treatment Period (15 Weeks) | STARTED | Double-Blind Treatment Period - Part A: Soticlestat | 15 | |
| Part A: DB Treatment Period (15 Weeks) | STARTED | Open-Label Extension Period - Part B: Soticlestat | 0 | |
| Part A: DB Treatment Period (15 Weeks) | COMPLETED | Double-Blind Treatment Period - Part A: Placebo | 6 | |
| Part A: DB Treatment Period (15 Weeks) | COMPLETED | Double-Blind Treatment Period - Part A: Soticlestat | 12 | |
| Part A: DB Treatment Period (15 Weeks) | COMPLETED | Open-Label Extension Period - Part B: Soticlestat | 0 | |
| Part A: DB Treatment Period (15 Weeks) | NOT COMPLETED | Double-Blind Treatment Period - Part A: Placebo | 3 | |
| Part A: DB Treatment Period (15 Weeks) | NOT COMPLETED | Double-Blind Treatment Period - Part A: Soticlestat | 3 | |
| Part A: DB Treatment Period (15 Weeks) | NOT COMPLETED | Open-Label Extension Period - Part B: Soticlestat | 0 | |
| Part B: OL Extension Period (14 Weeks) | STARTED | Double-Blind Treatment Period - Part A: Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Placebo | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Soticlestat | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Extension Period - Part B: Soticlestat | 1 | 18 | |
| other | Constipation | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Placebo | 1 | 9 | |
| other | Constipation | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Soticlestat | 2 | 15 | |
| other | Constipation | Gastrointestinal disorders | Open-Label Extension Period - Part B: Soticlestat | 1 | 18 | |
| other | Dry mouth | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Placebo | 0 | 9 | |
| other | Dry mouth | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Soticlestat | 2 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Open-Label Extension Period - Part B: Soticlestat | 0 | 18 | |
| other | Nausea | Gastrointestinal disorders | Double-Blind Treatment Period - Part A: Placebo | 1 | 9 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Treatment Period - Part A: Placebo | 0 | 9 |
| Total, all-cause mortality | Double-Blind Treatment Period - Part A: Soticlestat | 0 | 15 |
| Total, all-cause mortality | Open-Label Extension Period - Part B: Soticlestat | 0 | 18 |
| Total, other adverse events | Double-Blind Treatment Period - Part A: Placebo | 9 | 9 |
| Total, other adverse events | Double-Blind Treatment Period - Part A: Soticlestat | 12 | 15 |
| Total, other adverse events | Open-Label Extension Period - Part B: Soticlestat | 10 | 18 |
| Total, serious adverse events | Double-Blind Treatment Period - Part A: Placebo | 0 | 9 |
| Total, serious adverse events | Double-Blind Treatment Period - Part A: Soticlestat | 3 | 15 |
| Total, serious adverse events | Open-Label Extension Period - Part B: Soticlestat | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36538782 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03990649
GET https://conductscience.org/api/trials/v1/NCT03990649/results?page=2