Status:
UNKNOWN
MLC901 in Moderate Traumatic Brain Injury
Lead Sponsor:
University of the Philippines
Conditions:
Moderate Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
Detailed Description
This is a double blind placebo controlled randomized trial to determine whether giving MLC901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04766281
Start Date
May 1 2021
End Date
July 31 2024
Last Update
June 13 2023
Active Locations (3)
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1
Mariano Marcos Memorial Hospital and Medical Center
Batac, Ilocos Norte, Philippines
2
Northern Mindanao Medical Center
Cagayan de Oro, Misamis Oriental, Philippines, 9000
3
Philippine General Hospital
Manila, Philippines, 1000