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

NCT03954041 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-11-27

Study results available
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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

  • Brain Contusion

Interventions

DRUG

BIIB093

Administered as specified in the treatment arm.

DRUG

Placebo

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • Remedy Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Remedy Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-06
Primary Completion
2023-06-27
Completion
2023-06-27
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954041 on ClinicalTrials.gov