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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).
SHINKEI Therapeutics, Inc·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Traumatic Brain Injury
Drug/Device/Intervention
Amantadine Hydrochloride
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
SHINKEI Therapeutics, Inc
Timeline & enrollment
Phase
Phase 2
Start date
Feb 28, 2024
End date
Aug 01, 2024
Enrollment
45 participants
Primary outcome

Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups

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.

ICD-10 classifications
Diffuse brain injuryIntracranial injuryFocal brain injuryIntracranial injury, unspecifiedOther intracranial injuries
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06253923
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06253923 through Pure Global AI's free database. This Phase 2 trial is sponsored by SHINKEI Therapeutics, Inc and is currently Not yet recruiting. The study focuses on Traumatic Brain Injury. Target enrollment is 45 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.