Valproic AcId for Traumatic BRAin INjury Trial
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorthwestern University
About this trial
The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).
Patients with moderate to severe TBI will randomly receive either:
1. Standard of care treatment and normal saline 2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
Eligibility criteria
Qualifiers
Male or female between the ages of 18 and 65 years.
Body Mass Index between 18 kg/m2 and 35 kg/m2.
Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
Disqualifiers
Persons with known history of adverse reactions to VPA
Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
Persons with a known history of thrombocytopenia.
Persons with platelet count less than 100,000 per microliter of blood.
Trial design
Treatments tested in this trial
- Valproic Acid (VPA)
- Standard of care treatment + normal saline
Treatment groups
432 Participants
are divided into 2 treatment groupsLocations
8Alabama
University of Alabama at Birmingham35294, Birmingham United States
Arizona
University of Arizona85719-4824, Tucson United States
California
University of Southern California90089-0701, Los Angeles United States
University of California, Davis95817, Sacramento United States
Sponsors and collaborators
Northwestern University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov