Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

Phase 2 Terminated 265 enrolled Biogen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score. The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

Timeline

Start: 2018-05-31
Primary completion: 2021-04-12
Completion: 2021-04-12

Outcome

Mixed primary results

Stopped (Business): “Sponsor decision to close study early; not due to safety concerns”

paper FINDINGS: A statistically significant difference from placebo in least squares mean reduction in ADP score from baseline to DB Week 12 was observed with vixotrigine 200 mg BID PMID 37152360 ↗

paper In our study, vixotrigine 200 mg BID, but not 350 mg BID, met the primary endpoint PMID 37152360 ↗

release “The CONVEY study 200 mg twice daily arm met its primary endpoint” biogen.com ↗

release “Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at week 12.” biogen.com ↗

Publications

Faber CG, Attal N, Lauria G, Dworkin RH, Freeman R, Dawson KT, Finnigan H, Hajihosseini A, Naik H, Serenko M, Morris CJ, Kotecha M. Efficacy and safety of vixotrigine in idiopathic or diabetes-associated painful small fibre neuropathy (CONVEY): a phase 2 placebo-controlled enriched-enrolment randomised withdrawal study. EClinicalMedicine. 2023 Apr 27;59:101971. doi: 10.1016/j.eclinm.2023.101971. eCollection 2023 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vixotrigine	Small molecule	200 mg	Oral
Subject	Vixotrigine	Small molecule	350 mg	Oral