Phase 2
N=24
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
Complex Regional Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03990649 ↗Enrolled (actual)
24
Serious AEs
7.1%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A — -0.74; -1.05 scores on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Soticlestat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A |
-0.74; -1.05 | — |
| SECONDARY Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A |
-12.20; -18.35 | — |
| SECONDARY Percentage of Participants Considered Responders at the End of Part A |
22.2; 26.7 | — |
| SECONDARY Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A |
1.53; 2.39; 3.29; -1.99; 1.15; -0.78 | — |
| SECONDARY Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A |
4.27; 8.00; 9.35; -2.43; 4.51; 0.04 | — |
| SECONDARY Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A |
33.3; 33.3; 11.1; 13.3; 22.2; 33.3 | — |
| SECONDARY Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A |
-2.2; -3.1 | 0.540 |
| SECONDARY Percent Change From Baseline in CSS at the End of Part A |
-16.1; -23.8 | — |
Summary
The purpose of this study is to investigate the effect of soticlestat (TAK-935) on calculated 24-hour average pain intensity by the numeric pain scale (NPS).
Eligibility Criteria
Inclusion Criteria
- Participant meets the Budapest clinical diagnosis of complex regional pain syndrome (CRPS) at the screening visit and is at least 6 months since onset of symptoms.
- Participant's pain medications and nondrug treatments must be stable (regimented per prescription) for 1 month prior to screening and remain stable throughout Part A.
- Participant agrees to use a single previously prescribed rescue medication within the prescribed dose during Part A of the study and to record the daily use of these medications.
- Participant must have an average 24-hour pain intensity score ≥4 and ≤9 on the 24-hour average pain intensity numeric pain scale (NPS) during screening/baseline. This score will be calculated by averaging the daily 24 hour pain intensity scores for the past seven days prior to randomization. The participant must have daily 24-hour pain intensity scores recorded for at least 6 of the past 7 days.
Exclusion Criteria
- Currently receiving intravenous (IV) or oral ketamine, history of IV or oral ketamine use within the past 6 weeks prior to screening, or planned use of IV or oral ketamine during this study.
- Participant is receiving chronic opioid treatment at a dose that has not been stable 28 days prior to screening.
- Participant is receiving chronic opioid treatment >160 mg of morphine equivalent per day.
- Participant has a positive drug screen for phencyclidine, amphetamine/ methamphetamine, or cocaine at screening. Cannabis is allowed..
- Participant is positive for hepatitis B or hepatitis C infection at screening. (Note that participants who have been vaccinated against hepatitis B [hepatitis B surface antibody {Ab}-positive] who are negative for other markers of prior hepatitis B infection [eg, negative for hepatitis B core Ab] are eligible. Also, note that participants who are positive for hepatitis C Ab are eligible if they have a negative hepatitis C viral load by quantitative polymerase chain reaction).
Data sourced from ClinicalTrials.gov (NCT03990649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.