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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


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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