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
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
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Bad Neustadt/Saale, Bavaria 97616, Germany
Naharya, Northern District 22100, Israel
Monza Brianza, Milano 20900, Italy
Pama, Parma 43126, Italy
Milan, 20162, Italy
Kisarazu-Shi, Chiba 292-8535, Japan
Kobe, Hyōgo 650-0047, Japan
Ube-Shi, Yamaguchi 755-8505, Japan