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ACTIVE NOT RECRUITING
NCT06253923
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Amantadine Hydrochloride

MR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).

DRUG

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