Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) i… (NCT06253923) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
United States45 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Life expectancy of less than 24 hours.
✕. Patient has any spinal cord injury.
✕
What they're measuring
1
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups
✕. 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.