Trials / Terminated
TerminatedNCT03954041
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Remedy Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB093 | Administered as specified in the treatment arm. |
| DRUG | Placebo | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2019-10-06
- Primary completion
- 2023-06-27
- Completion
- 2023-06-27
- First posted
- 2019-05-17
- Last updated
- 2024-11-27
- Results posted
- 2023-12-20
Locations
63 sites across 7 countries: United States, France, Germany, Israel, Italy, Japan, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03954041. Inclusion in this directory is not an endorsement.