NCT07166393

Valproic AcId for Traumatic BRAin INjury Trial

Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Moderate Traumatic Brain Injury (TBI)
• Severe Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Valproic Acid (VPA)	VPA (in 250 ml 0.9% sodium chloride solution)
OTHER	Standard of care treatment + normal saline	Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-02-01
• Completion: 2030-12-01
• First posted: 2025-09-10
• Last updated: 2025-09-22

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study