MLC901 in Moderate Traumatic Brain Injury

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

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

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.

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