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

NCT01454154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-11-12

No results posted yet for this study

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

Interventions

DRUG

Glyburide

Administered as specified in the Treatment Arm.

DRUG

Placebo

Administered as specified in the Treatment Arm.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

    collaborator OTHER

  • Remedy Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Remedy Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-17
Primary Completion
2015-02-20
Completion
2015-02-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454154 on ClinicalTrials.gov