Overview

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

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2025-08-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE2

Details

Lead Sponsor:

SHINKEI Therapeutics, Inc

Collaborator:

Duke Clinical Research Institute

Treatments:

Amantadine