A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion (ASTRAL)
Brain Contusion
About this trial
This is an interventional treatment trial for Brain Contusion
Eligibility Criteria
Key Inclusion Criteria:
- Clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling > 3 mL in volume per Investigator assessment of baseline non-contrast computed tomography scan (NCCT) at Screening.
- A score of 5 to 15 on the Glasgow Coma Scale (GCS)
- Functionally independent, in the opinion of the Investigator, prior to index head injury.
Key Exclusion Criteria:
- In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.
- Clinical signs of brainstem herniation, in the opinion of the Investigator.
- NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain parenchyma. Cerebrospinal fluid leak in isolation is not exclusionary unless evidence of parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed skull fracture).
- Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination.
- Presence of concomitant spinal cord injury as assessed by imaging and clinical examination.
- Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management, if known. Minor fractures requiring splinting or reduction of dislocations are permitted, as are nonoperative intra-abdominal injuries or placement of noninvasive external fixation devices.
- Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3 days prior to the injury, if known.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Barrow Neurological Institute
- Scottsdale Healthcare Hospitals d/b/a HonorHealth
- University of Arizona Medical Center
- Yale New Haven Hospital
- Grady Memorial Hospital
- WellStar Medical Group Neurosurgery
- Goodman Campbell Brain and Spine
- University Medical Center New Orleans
- University of Maryland Medical Center
- Tufts Medical Center
- Massachusetts General Hospital
- Northwell Health
- University of North Carolina at Chapel Hill
- Vidant Medical Center
- Wake Forest Baptist Health Sciences
- University of Cincinnati College of Medicine
- Miami Valley Hospital
- ProMedica Toledo Hospital
- Oregon Health & Science University
- Thomas Jefferson University
- Rhode Island Hospital
- UT Southwestern Medical Center
- The University of Texas Health Science Center at Houston
- University of Utah Health
- Virginia Commonwealth University Medical Center
- CHU de Brest - Hôpital de la Cavale Blanche
- Hopital Caremeau
- Groupe Hospitalier Pellegrin - Hôpital Pellegrin
- CHU Rennes - Hôpital Pontchaillou
- CHU Clermont Ferrand - Hopital Gabriel Montpied
- CHU Amiens - Hopital Sud
- Universitaetsklinikum Heidelberg
- Neurologische Klinik Bad Neustadt/Saale
- Universitaetsmedizin Goettingen
- Universitaetsklinikum Schleswig-Holstein - Campus Kiel
- Rabin MC
- Health Corporation of Galilee Medical Center
- Chaim Sheba Medical Center
- Rambam Health Care Center
- Shaare Zedek Medical Center
- Hadassah
- Tel Aviv Sourasky Medical Center
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
- ASST Monza - Ospedale San Gerardo di Monza
- Azienda Ospedaliero Universitaria di Parma
- Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
- Ospedale Maggiore di Novara
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
- Kimitsu Chuo Hospital
- Kobe City Hospital Organization Kobe City Medical Center General Hospital
- Nara Medical University Hospital
- Rinku General Medical Center
- Nippon Medical School Hospital
- Yamaguchi University Hospital
- Hospital Universitari Son Espases
- Complejo Hospitalario Universitario de Santiago
- Hospital Alvaro Cunqueiro
- Hospital Universitari Vall d'Hebron
- Hospital Universitari de Bellvitge
- Hospital Universitario Reina Sofia
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
BIIB093 3 mg
BIIB093 5 mg
Placebo 3 mg
Placebo 5 mg
Participants will be administered BIIB093 3 milligram per day (mg/day) as a bolus followed by rapid and slow intravenous (IV) infusions for 96 hours.
Participants will be administered BIIB093 5 mg/day as a bolus followed by rapid and slow IV infusions for 96 hours.
Participants will be administered matching placebo to BIIB093 as a bolus followed by rapid and slow IV infusions for 96 hours.
Participants will be administered matching placebo to BIIB093 as a bolus followed by rapid and slow IV infusions for 96 hours.