Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
Northwestern University
Summary
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
Description
The specific aim is to determine whether giving VPA at either a 50 mg/kg dose or a 100 mg/kg is safe (as measured by adverse events after treatment) in patients with moderate to severe TBI due to brain bruises.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female between the ages of 18 and 65 years. 2. Body Mass Index between 18 kg/m2 and 35 kg/m2. 3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test. 4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12. 5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria Exclusion Criteria: 1. Persons with known history of adverse reactions to VPA 2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunctio…
Interventions
- DrugValproic Acid (VPA)
VPA (in 250 ml 0.9% sodium chloride solution)
- OtherStandard of care treatment + normal saline
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Locations (8)
- University of Alabama at BirminghamBirmingham, Alabama
- University of ArizonaTucson, Arizona
- University of Southern CaliforniaLos Angeles, California
- University of California, DavisSacramento, California
- Oregon Health & Science UniversityPortland, Oregon
- Vanderbilt University Medical CenterNashville, Tennessee