Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI). - Trial NCT06253923
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.
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Study Focus
Sponsor & Location
SHINKEI Therapeutics, Inc
Timeline & Enrollment
Phase 2
Feb 28, 2024
Aug 01, 2024
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
Data Source
ClinicalTrials.gov
NCT06253923
Non-Device Trial