Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI). (NCT06253923)
Multicenter, Double-blind, Randomized, Placebo Controlled, Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301), in Patients With Severe Traumatic Brain Injury (TBI).
🩺 Plain-English Summary (8th-Grade Level)
The main goal of this clinical trial is to check if the treatment is safe and well-tolerated. Researchers will compare the MR-301 active drug group with the placebo group to evaluate the safety and tolerability of the drug. Other measurements include assessing the patient's overall outcome, neurological responses, time spent in the intensive care unit, time in the hospital, and mortality. Participants will receive either MR-301 BID IV dosing or a matching placebo for a total of 3 weeks.
Who can join: Review the eligibility criteria below.
Location: Los Angeles General Medical Center — Los Angeles, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Los Angeles General Medical Center — Los Angeles, California
- UC Davis Medical Center — Sacramento, California
- UF Health Heart and Vascular Hospital — Gainesville, Florida
- Tampa General Hospital — Tampa, Florida
- Maine Medical Center — Portland, Maine
- Wayne State University — Detroit, Michigan
- Barnes Jewish Hospital — St Louis, Missouri
- Hackensack Meridian Health Jersey Shore University Medical Center — Neptune City, New Jersey
- University of New Mexico Hospital — Albuquerque, New Mexico
- Department of Neurology, Duke University School of Medicine — Durham, North Carolina
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania
- McGovern Medical School, University of Texas Health Science Center — Houston, Texas
- Medical College of Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury
- Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI) — San Francisco, California
- Improving Time-Based Prospective Memory in TBI — East Hanover, New Jersey
- Re-entry Continuum for Brain Injury — Greencastle, Indiana
- Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury — Minneapolis, Minnesota
- TRACK-TBI Longitudinal Biomarker Study — San Francisco, California
- Narrative Discourse Treatment Development — West Haven, Connecticut
Explore by condition: All Traumatic Brain Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.