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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
MR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).
The placebo for this study is 0.9% Sodium Chloride IV Solution.
Los Angeles General Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UF Health Heart and Vascular Hospital
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Maine Medical Center
Portland, Maine, United States
Wayne State University
Detroit, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Department of Neurology, Duke University School of Medicine
Durham, North Carolina, United States
...and 3 more locations
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups
Safety and tolerability will be compared between active treatment and placebo groups.
Time frame: Day 1 to Day 35
Change from baseline in Glasgow Outcome Scale-Extended
Time frame: Day 21 and Day 35
Change from baseline in Disability Rating Scale (DRS) scale
Time frame: Day 5, Day 10, Day 15, Day 21
Change from baseline in Coma Recovery Scale - Revised
Time frame: Day 5, Day 10, Day 15, Day 21
Change from baseline in Full Outline of UnResponsiveness (FOUR) score
Time frame: every day up to Day 21
Time to intensive care unit (ICU) discharge to hospital floor
Time frame: up to day 21
Time to hospital discharge from randomization
Time frame: up to day 21
Mortality assessment at end of treatment period
Time frame: Day 21
Mortality assessment at end of study period (Day 35).
Time frame: Day 35
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