Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
Status:
Completed
Trial end date:
2015-02-20
Target enrollment:
Participant gender:
Summary
The primary objectives of this study are to assess whether participants with traumatic brain
injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in
magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to
assess the safety and tolerability of glyburide compared to placebo in participants with TBI.
The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan
/MRI abnormalities, reduction of mortality and or improvement of function or physiology,
incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady
state concentrations of glyburide in TBI participants.
Phase:
Phase 2
Details
Lead Sponsor:
Biogen Remedy Pharmaceuticals, Inc.
Collaborators:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command