NCT01454154

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

A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Remedy Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Glyburide	Administered as specified in the Treatment Arm.
DRUG	Placebo	Administered as specified in the Treatment Arm.

Timeline

• Start date: 2011-12-17
• Primary completion: 2015-02-20
• Completion: 2015-02-20
• First posted: 2011-10-18
• Last updated: 2024-11-12

Locations

4 sites across 1 country: United States