Traumatic Brain Injury Clinical Trial
Official title:
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).
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.
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. ;
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