Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT06253923

Run by

SHINKEI Therapeutics, Inc

People needed

45

Starts

2024-06-01

Expected to finish

2025-08-01

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 to 75 years.
• Patients with TBI confirmed by CT scan or MRI
• Patient have sustained a trauma between 72 hours to 1 week
• Patient with Abbreviated Injury Score (AIS) ≤ 2.
• Patients must be admitted to an acute care setting no less than 2 days prior to randomization.
• Glasgow Coma Score of 3 to 8, inclusive.
• Patients must be unable to consistently follow commands or to engage in functional communication, as assessed by the score on the CRS-R.
• Patients have at least one reactive pupil.
• Must have a Legally Authorized Representative (LAR) able to provide consent for the trial.
• 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)].

You may not qualify if…

• Life expectancy of less than 24 hours.
• Patient has any spinal cord injury.
• Patient has a penetrating head injury.
• Patient has bilaterally fixed dilated pupils
• 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.
• Patient has poorly controlled seizure more than one per month.
• Prior history of status epilepticus
• Prior treatment with or a sensitivity to amantadine HCl or amantadine.
• Patient has screening lab measurements outside the normal range
• Absolute neutrophil count (ANC): ≤ 1.5 x 109/L
• Hemoglobin ≤ 8 g/dL or active bleeding requiring ongoing transfusions.
• Platelets ≤ 80 x 109/L or active bleeding requiring ongoing transfusions.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin (unless isolated Gilbert's syndrome) ≥ 2x the upper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
• Patient has received treatment with an investigational drug, CNS stimulant or dopamine antagonist/agonist within 4 weeks.
• Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the last 5 years.
• Females who are nursing, pregnant, or planning to become pregnant
• any other clinically significant medical condition as determined by the Investigator, that may unfavorably alter the risk benefit of study participation.
• Patient has prolonged QT interval.
• Treatment with a systemic anticholinergic medication within 1 week prior to screening.

Where it is running

• 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
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• McGovern Medical School, University of Texas Health Science Center — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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