Phase 2Terminated
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion (ASTRAL)
A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion
- Sponsor
- Remedy Pharmaceuticals, Inc. (Industry)
- Enrollment
- 92 enrolled
- Conditions
- Brain Contusion
- Interventions
- BIIB093; Placebo
- Ages
- adults, older adults
- Registry
- NCT03954041, EUCTR2018-003858-24
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
History
Last registry update
Results first posted
Primary completion
Started
Registered