Amantadine Hydrochloride: MR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).
Placebo: The placebo for this study is 0.9% Sodium Chloride IV Solution.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age: 18 to 75 years.
2. Patients with TBI confirmed by CT scan or MRI
3. Patient have sustained a trauma between 72 hours to 1 week
4. Patient with Abbreviated Injury Score (AIS) ≤ 2.
5. Patients must be admitted to an acute care setting no less than 2 days prior to randomization.
6. Glasgow Coma Score of 3 to 8, inclusive.
7. Patients must be unable to consistently follow commands or to engage in functional communication, as assessed by the score on the CRS-R.
8. Patients have at least one reactive pupil.
9. Must have a Legally Authorized Representative (LAR) able to provide consent for the trial.
10. Patient must have stable vitals ---Intracranial pressure ICP Value is at discretion of investigator), systolic blood pressure (SBP\>90 mmHg) partial pressure of oxygen (PaO2 \> 60 mmHg)\].
Exclusion Criteria:
1. Life expectancy of less than 24 hours.
2. Patient has any spinal cord injury.
3. Patient has a penetrating head injury.
4. Patient has bilaterally fixed dilated pupils
5. Patients with history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with clinical assessment.
6. Patient has poorly controlled seizure more than one per month.
7. Prior history of status epilepticus
8. Prior treatment with or a sensitivity to amantadine HCl or amantadine.
9. Patient has screening lab measurements outside the normal range
1. Absolute neutrophil count (ANC): ≤ 1.5 x 109/L
2. Hemoglobin ≤ 8 g/dL or active bleeding requiring ongoing transfusions.
3. Platelets ≤ 80 x 109/L or active bleeding requiring ongoing transfusions.
4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin (unless isolated Gilbert's syndrome) ≥ 2x the upper limit of normal (ULN)
5. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
10. Patient has received treatment with an investigational drug, CNS stimulant or dopamine antagonist/agonist within 4 weeks.
11. Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the last 5 years.
12. Females who are nursing, pregnant, or planning to become pregnant
13. any other clinically significant medical condition as determined by the Investigator, that may unfavorably alter the risk benefit of study participation.
14. Patient has prolonged QT interval.
15. Treatment with a systemic anticholinergic medication within 1 week prior to screening.
Primary outcome measure(s)
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups — Day 1 to Day 35 Safety and tolerability will be compared between active treatment and placebo groups.
Trial sites (13)
Facility
City
Region
Status
Los Angeles General Medical Center
Los Angeles
California
UC Davis Medical Center
Sacramento
California
UF Health Heart and Vascular Hospital
Gainesville
Florida
Tampa General Hospital
Tampa
Florida
Maine Medical Center
Portland
Maine
Wayne State University
Detroit
Michigan
Barnes Jewish Hospital
St Louis
Missouri
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City
New Jersey
University of New Mexico Hospital
Albuquerque
New Mexico
Department of Neurology, Duke University School of Medicine
Durham
North Carolina
Penn Presbyterian Medical Center
Philadelphia
Pennsylvania
McGovern Medical School, University of Texas Health Science Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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