Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial

SJREB-2020-94

This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.

2021-05-01

2024-05-30

2024-07-31

Recruiting

Early phase I

120

Inclusion Criteria: * Age 18-65 years * Moderate TBI * Presenting at the study site within 7 days of injury * Participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent Exclusion Criteria: * Penetrating HI * Co-existing severe or unstable injury * Physician's medical judgment that surgical intervention is likely within the next 48 hours * Physician's medical judgment that participation is not in the participant's best interest * Pre-injury mRS\>2 * Pregnancy * Inability to take study drug orally or via NGT * Participation in another investigational drug study * Intake of nootropic drugs which are not standard TBI medications

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to receive either MLC901 or placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-06-13