University of California, San Francisco
The purpose of this study is to determine if experimental drug treatment improves recovery after TBI as compared to a control (placebo) group. Changes in recovery will be measured throughout the study. The study drugs listed below are approved by the U.S. Food and Drug Administration (FDA) but are being used "off-label" in this study. This means that the drugs are not currently approved to treat TBI.
Inclusion Criteria: 1. Adults (18-65 years of age, inclusive) 2. Presents to a participating enrollment site and is able to receive first dose within 24 hours of non-penetrating head injury warranting clinical evaluation with a non-contrast head CT based on American College of Emergency Physicians (ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for TBI imaging. 3. Closest, prior to Randomization Glasgow Coma Scale (GCS) score of 9 to 15 4. Acute trauma-related neuroimaging abnormality (subarachnoid hemorrhage, contusion, subdural hematoma, petechial hemorrhage, intrave…
Capsule, 80 mg/day, with no loading dose, for 28 days
Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
Capsule, 2x/day for 28 days