Status:
UNKNOWN
MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)
Lead Sponsor:
Ali Amini Harandi
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
15-65 years
Phase:
PHASE4
Brief Summary
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules thr...
Eligibility Criteria
Inclusion
- age between 15 and 65
- non-penetrating moderate (Glasgow Coma Scale score \[GCS\] 9-12) or severe (GCS 3-8) traumatic brain
- injury less than 24 hrs from traumatic injury
- anticipated intensive care unit length of stay at least 48 hrs
Exclusion
- GCS = 3 and fixed dilated pupils or penetrating injury
- coexisting injury or medical conditions which could adversely affect our study outcome measures
- dependence for everyday activities before the injury
- pregnancy or breastfeeding
- known allergy to any of MLC901 components
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04487275
Start Date
August 20 2018
End Date
October 1 2020
Last Update
July 27 2020
Active Locations (1)
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1
Brain Mapping Research Center
Tehran, Iran