Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01454154
Study type	Interventional
Source	Remedy Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	December 17, 2011
Completion date	February 20, 2015

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