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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
672
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
University of California, San Francisco
San Francisco, California, United States
Indiana University Health
Indianapolis, Indiana, United States
Change in Glasgow Outcome Scale-Extended (GOSE 2-Way)
Functional impairment due only to the TBI will be measured using the GOSE Scale-Extended (GOSE 2-Ways). The score ranges from 1-8, with higher scores indicating better recovery. Change will be measured from Week 2 to Month 3 postinjury and compared to placebo.
Time frame: 2 weeks to 3 months postinjury
Change in Blood-based biomarkers (Neurofilament light chain)
Neurofilament light chain (NfL) levels postinjury in participants with TBI will be measured and compared to placebo
Time frame: Week 2
Blood-based biomarker (GFAP)
GFAP levels postinjury in participants with TBI as compared to placebo
Time frame: Week 2
Imaging biomarkers
Comparison of MRI diffusion tensor imaging (DTI) Axial Diffusivity (AD) measure using the average of 4 long association/projections tracts: (i) Anterior Limb of Internal Capsule (ALIC); (ii) External Capsule (EC); (iii) Superior Corona Radiata (SCR); and (iv) Superior Longitudinal Fasciculus (SLF). Change will be measured from 2 Weeks to 3 Months postinjury.
Time frame: 2 weeks to 3 months postinjury
Post-TBI cognitive outcome (BTACT)
Neurocognitive impairment due to TBI will be measured using the Brief Test of Adult Cognition by Telephone (BTACT). Change will be measured by composite z-score from Day 3 to Week 4 postinjury
Time frame: Day 3 to Week 4 postinjury
Post-TBI symptom outcome (Rivermead)
Post-concussive symptoms due to TBI as measured by the change in Rivermead Post Concussion Symptoms Questionnaire (RPQ) Total score (0-64) from Day 3 to Week 4. Higher scores indicate more severe symptoms
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Capsule, 2x/day for 28 days
University of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Atrium Health Wake Forest Baptist
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
...and 8 more locations
Time frame: Day 3 to Week 4