Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

Summary

The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy \[DC\] or comfort measures only \[CMO\], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI. The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

Timeline

Start

2018-08-29

Primary completion

2023-08-18

Completion

2023-08-18

Publications

• Sheth KN, Albers GW, Saver JL, Campbell BCV, Molyneaux BJ, Hinson HE, Cordonnier C, Steiner T, Toyoda K, Wintermark M, Littauer R, Collins J, Lucas N, Nogueira RG, Simard JM, Wald M, Dawson K, Kimberly WT; CHARM Trial investigators. Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Neurol. 2024 Dec;23(12):1205-1213. doi: 10.1016/S1474-4422(24)00425-3.
• Shu L, Zhang W, Yaghi S, Grilli A, de Havenon A, Barrett KM, Johnston KC, Goldstein ED. Prestroke and Poststroke Sulfonylurea Exposure and Functional Outcomes: A Post Hoc Analysis of the SHINE Trial. Stroke. 2023 Sep;54(9):e415-e416. doi: 10.1161/STROKEAHA.123.043496. Epub 2023 Jul 14. No abstract available.

Drugs

Indications