Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)

Phase 2 Completed 24 enrolled Millennium Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2019-07-23
Primary completion: 2020-06-29
Completion: 2020-10-28

Outcome

Missed primary endpoint

paper resulting in a non-significant placebo-adjusted difference of -0.34 (-1.55, 0.88; P = .570). PMID 36538782 ↗

paper Adjunctive soticlestat treatment did not significantly reduce pain intensity in participants with chronic CRPS. PMID 36538782 ↗

Publications

Ratcliffe S, Arkilo D, Asgharnejad M, Bhattacharya S, Harden RN. Randomized controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in adults with complex regional pain syndrome. Pain Med. 2023 Jul 5;24(7):872-880. doi: 10.1093/pm/pnac198.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Soticlestat	Small molecule	300 mg	Oral