What this study is
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
What's being tested
- Valproic Acid (VPA)
Intervention · DRUG
VPA (in 250 ml 0.9% sodium chloride solution)
- Standard of care treatment + normal saline
Intervention · OTHER
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Study details
- Official title
- Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
- Sponsor
- Northwestern University
- Conditions
- Moderate Traumatic Brain Injury (TBI) · Severe Traumatic Brain Injury
- Enrolling
- 432 people
- Starts
- 2027-05
- Est. completion
- 2031-12
- Design
- Triple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3) criteria
You can't join if
- 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.
- Persons with 2nd or 3rd degree burns of any size and location.
- Female subjects who are pregnant or lactating.
- Persons who are currently incarcerated or are in police custody.
- Persons with inadequate venous access.
- Treatment cannot start within 120 minutes from the onset of injury
- Non-survivable injuries in the estimation of the attending trauma surgeon.
- Interfacility transfers
- The time of injury is unknown
- Patients in hemorrhagic shock with a systolic blood pressure of <90 mmHg on initial evaluation.
- Persons with a known "do not resuscitate" order prior to randomization
- Persons with a research "opt out" bracelet
- Persons who are currently enrolled in another clinical trial.
- Greater than 90 minutes between the onset of injury and arrival to the hospital
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Joel Rodgers · Contact205-515-3590jrodgers@uabmc.edu
- Jan Jansen, MD · Principal investigator
University of Arizona
Tucson, Arizona, United States
- Robin Carlson, PhD · Contact520-626-2876rscarlson@arizona.edu
- Joseph Bellal, MD · Principal investigator
University of Southern California
Los Angeles, California, United States
- Monica Wong · Contact323-409-8597monica.wong@med.usc.edu
- Matthew Martin, MD · Principal investigator
- Kenji Inaba, MD · Sub-investigator
University of California, Davis
Sacramento, California, United States
- Shari Nichols · Contactslnichols@health.ucdavis.edu
- Rachael Callcut, MD · Principal investigator
- Rachel Russo, MD · Sub-investigator
Northwestern University
Chicago, Illinois, United States
- Sharnia Lashley, MS · Contact312-503-3856sharnia.lashley@northwestern.edu
- Nicole Meredyth, MD · Principal investigator
- Michael Shapiro, MD · Sub-investigator
- Todd Parrish, PhD · Sub-investigator
- Denise Scholtens, PhD · Sub-investigator
Oregon Health & Science University
Portland, Oregon, United States
- Samanatha Underwood · Contact503-494-5400underwos@ohsu.edu
- Mitchell Sally, MD · Principal investigator
Vanderbilt University Medical Center
Nashville, Tennessee, United States
- Heather White · Contact615-421-2996Heather.white@vumc.org
- Amelia Maiga, MD · Principal investigator
- Mayur Patel, MD · Sub-investigator
University of Texas Southwestern
Dallas, Texas, United States
- Katherine Bosler · Contactkatherine.bosler@utsowthwestern.edu
- Linda Dultz, MD · Principal investigator
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Madison Rundell, BS · Contactmrundell@mcw.edu
- Marc de Moya, MD · Principal investigator
Study team
Sponsor
Northwestern University
Study ID STU00223546
Principal investigator
Hasan Alam, MD
Northwestern University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.