Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

August 31, 2025

Conditions
Traumatic Brain Injury
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.

Trial Locations (13)

19104

Penn Presbyterian Medical Center, Philadelphia

27705

Department of Neurology, Duke University School of Medicine, Durham

32608

UF Health Heart and Vascular Hospital, Gainesville

33606

Tampa General Hospital, Tampa

48201

Wayne State University, Detroit

53226

Medical College of Wisconsin, Milwaukee

63110

Barnes Jewish Hospital, St Louis

77030

McGovern Medical School, University of Texas Health Science Center, Houston

87106

University of New Mexico Hospital, Albuquerque

90033

Los Angeles General Medical Center, Los Angeles

95817

UC Davis Medical Center, Sacramento

04102

Maine Medical Center, Portland

07753

Hackensack Meridian Health Jersey Shore University Medical Center, Neptune City

Sponsors
All Listed Sponsors
collaborator

Duke Clinical Research Institute

OTHER

lead

SHINKEI Therapeutics, Inc

INDUSTRY