Evaluating MLC901 for 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 is testing if a new treatment called MLC901 can help adults with moderate traumatic brain injuries recover better than standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of the Philippines Academic / other |
| Locations | 3 sites (Batac, Ilocos Norte and 2 other locations) |
| Trial ID | NCT04766281 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of MLC901 in improving outcomes for adult patients suffering from moderate traumatic brain injury. It is designed as a double-blind, placebo-controlled, randomized trial, where participants will receive either MLC901 or a placebo for a duration of six months. The study will enroll adults aged 18 to 65 who present within seven days of their injury, ensuring timely intervention. The primary goal is to determine if MLC901 can lead to significant improvements in recovery compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have sustained a moderate traumatic brain injury and can provide informed consent.
Not a fit: Patients with severe or unstable injuries, those requiring immediate surgical intervention, or those with pre-existing conditions that may complicate treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery and quality of life for patients with moderate traumatic brain injury.
How similar studies have performed: While there have been studies on treatments for traumatic brain injury, the specific use of MLC901 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Batac, Ilocos Norte and 2 other locations
- Mariano Marcos Memorial Hospital and Medical Center — Batac, Ilocos Norte, Philippines (Recruiting)
- Northern Mindanao Medical Center — Cagayan De Oro, Misamis Oriental, Philippines (Recruiting)
- Philippine General Hospital — Manila, Philippines (Recruiting)
Study contacts
- Principal investigator: Annabell E Chua, MD — University of the Philippines Manila - Philippine General Hospital
- Study coordinator: Annabell E Chua, MD
- Email: aechua@up.edu.ph
- Phone: +632-85242338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.