drugset / Trial / NCT03954041

A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

NCT03954041

Phase 2 Terminated 92 enrolled Remedy Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

Timeline

Start
2019-10-06
Primary completion
2023-06-27
Completion
2023-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule 3 mg Intravenous
Subject Glyburide Small molecule 5 mg Intravenous

Indications