Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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
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.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Adhiraj Dharmadhikari
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal