NCT06253923

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

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).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: SHINKEI Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, randomized, placebo-controlled study of MR-301 administered BID IV in patients with severe TBI. Participant: 45 patients with severe TBI who maintain GCS scores 3-8 both inclusive. Intervention: Mr-301 or placebo will be administered intravenously BID for upto 3 weeks. Primary Outcome: Safety and Tolerability of MR-301 Secondary Outcome: GOS-E, CRS-R, DRS, FOUR score, time to ICU discharge, time to hospital discharge and mortality.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-07-31
• Completion: 2025-08-01
• First posted: 2024-02-12
• Last updated: 2025-07-15

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study