학술논문
Randomized controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in adults with complex regional pain syndrome.
Document Type
Academic Journal
Author
Ratcliffe S; St Pancras Clinical Research, London, EC2Y 8EA, United Kingdom.; Arkilo D; Takeda Pharmaceutical Company Limited, Cambridge, MA 02139, United States.; Asgharnejad M; Takeda Pharmaceutical Company Limited, Cambridge, MA 02139, United States.; Bhattacharya S; Takeda Pharmaceutical Company Limited, Cambridge, MA 02139, United States.; Harden RN; Departments of Physical Medicine and Rehabilitation and Physical Therapy and Human Movement Science, , Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.
Source
Publisher: published by Oxford University Press on behalf of the American Academy of Pain Medicine Country of Publication: England NLM ID: 100894201 Publication Model: Print Cited Medium: Internet ISSN: 1526-4637 (Electronic) Linking ISSN: 15262375 NLM ISO Abbreviation: Pain Med Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: The objective was to investigate the efficacy and safety of soticlestat as adjunctive therapy in participants with complex regional pain syndrome (CRPS).
Design: A proof-of-concept phase 2a study, comprising a 15-week randomized, double-blind, placebo-controlled, parallel-group study (part A), and an optional 14-week open-label extension (part B).
Methods: Twenty-four participants (median age 44.5 years [range, 18-62 years]; 70.8% female) with chronic CRPS were randomized (2:1) to receive oral soticlestat or placebo. Soticlestat dosing started at 100 mg twice daily and was titrated up to 300 mg twice daily. In part B, soticlestat dosing started at 200 mg twice daily and was titrated up or down at the investigator's discretion. Pain intensity scores using the 11-point Numeric Pain Scale (NPS) were collected daily. The Patient-Reported Outcomes Measurement Information System (PROMIS)-29, Patients' Global Impression of Change (PGI-C), and CRPS Severity Score (CSS) were completed at screening and weeks 15 and 29.
Results: From baseline to week 15, soticlestat treatment was associated with a mean change in 24-hour pain intensity NPS score (95% confidence interval) of -0.75 (-1.55, 0.05) vs -0.41 (-1.41, 0.59) in the placebo group, resulting in a non-significant placebo-adjusted difference of -0.34 (-1.55, 0.88; P = .570). Statistically non-significant numerical changes were observed for the PROMIS-29, PGI-C, and CSS at weeks 15 and 29.
Conclusions: Adjunctive soticlestat treatment did not significantly reduce pain intensity in participants with chronic CRPS.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.)
Design: A proof-of-concept phase 2a study, comprising a 15-week randomized, double-blind, placebo-controlled, parallel-group study (part A), and an optional 14-week open-label extension (part B).
Methods: Twenty-four participants (median age 44.5 years [range, 18-62 years]; 70.8% female) with chronic CRPS were randomized (2:1) to receive oral soticlestat or placebo. Soticlestat dosing started at 100 mg twice daily and was titrated up to 300 mg twice daily. In part B, soticlestat dosing started at 200 mg twice daily and was titrated up or down at the investigator's discretion. Pain intensity scores using the 11-point Numeric Pain Scale (NPS) were collected daily. The Patient-Reported Outcomes Measurement Information System (PROMIS)-29, Patients' Global Impression of Change (PGI-C), and CRPS Severity Score (CSS) were completed at screening and weeks 15 and 29.
Results: From baseline to week 15, soticlestat treatment was associated with a mean change in 24-hour pain intensity NPS score (95% confidence interval) of -0.75 (-1.55, 0.05) vs -0.41 (-1.41, 0.59) in the placebo group, resulting in a non-significant placebo-adjusted difference of -0.34 (-1.55, 0.88; P = .570). Statistically non-significant numerical changes were observed for the PROMIS-29, PGI-C, and CSS at weeks 15 and 29.
Conclusions: Adjunctive soticlestat treatment did not significantly reduce pain intensity in participants with chronic CRPS.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.)