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Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
Sponsor: SHINKEI Therapeutics, Inc
Summary
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.
Official title: 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).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-06-01
Completion Date
2025-08
Last Updated
2025-07-15
Healthy Volunteers
No
Conditions
Interventions
Amantadine Hydrochloride
MR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).
Placebo
The placebo for this study is 0.9% Sodium Chloride IV Solution.
Locations (13)
Los Angeles General Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UF Health Heart and Vascular Hospital
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Maine Medical Center
Portland, Maine, United States
Wayne State University
Detroit, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Department of Neurology, Duke University School of Medicine
Durham, North Carolina, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
McGovern Medical School, University of Texas Health Science Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States