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Title 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.
Therapeutic Area Brain Contusion
Principal Investigator Deborah Green-LaRoche, MD
Min Age 18 Years
Max Age 80 Years
Gender All
Contact Emma Jost-Price
617-636-7606
neuroresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03954041

Overview

The primary objective of this study is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. Secondary objectives and endpoints for the study 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.

Study Details

Inclusion Criteria

  • A clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling > 3 mL in volume on non-contrast computed tomography (NCCT) scan.
  • A score of 5 to 14 on the GCS.
  • Randomization must occur within 6 hours of time of trauma, if known, or last known normal (if time of trauma is unknown).

Exclusion Criteria

  • In the judgment of the Investigator, patient is likely to have supportive care withdrawn within 24 hours.
  • Intracranial hemorrhage due to causes other than TBI (e.g., spontaneous intracerebral hemorrhage, saccular/fusiform/infective aneurysm rupture), based on medical history of no trauma and location of the bleed.
  • Known allergy to BIIB093 or another sulfonylurea drug or any of the components of the formulated BIIB093 or matching placebo.

Study Requirements

This study will take place over approximately 180 days which includes a screening and enrollment period, a treatment period of 96 hours, and a follow-up period up to Day 180. There will be three follow-up visits after hospital discharge. Blood will be collected throughout the hospital visit (screening and treatment periods) up to seven times. At least 2 head CTs and 1 MRI will be performed during the study.