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Valproic AcId for Traumatic BRAin INjury Trial

NCT07166393 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2025-09-22

No results posted yet for this study

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

Conditions

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Hasan Alam, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-02-28
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07166393 on ClinicalTrials.gov