Clinical trial NCT04766281: MLC901 in Moderate Traumatic Brain Injury
Official title: Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Moderate Traumatic Brain Injury
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to receive either MLC901 or placebo
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: GOS-E at 6 months
timeFrame: 18 months
Secondary outcomes:
measure: Mortality at 6 months
timeFrame: 18 months
measure: Cerebral swelling at baseline, 1 & 2 weeks
timeFrame: 18 months
measure: Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months
timeFrame: 18 months
measure: Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months
timeFrame: 18 months
measure: Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months
timeFrame: 18 months
measure: Frontal Assessment Battery at 1,3,6 & 9 monts
timeFrame: 18 months
measure: RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months
timeFrame: 18 months
measure: Barthel Index (BI) at 1,3,6 & 9 months
timeFrame: 18 months
measure: Hospital Anxiety and Depression Scale at 1,3,6 & 9 months
timeFrame: 18 months
measure: EQ-5D at 1,3,6 & 9 months (EuroQol Group)
timeFrame: 18 months
measure: Safety until 9 months: adverse events
timeFrame: 18 months
measure: Compliance until 6 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Batac
country: Philippines
facility: Mariano Marcos Memorial Hospital and Medical Center
state: Ilocos Norte
city: Cagayan De Oro
country: Philippines
facility: Northern Mindanao Medical Center
state: Misamis Oriental
city: Manila
country: Philippines
facility: Philippine General Hospital
Study officials:
affiliation: University of the Philippines Manila - Philippine General Hospital
name: Annabell E Chua, MD
role: PRINCIPAL_INVESTIGATOR
References: