MLC901 in Moderate Traumatic Brain Injury

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

Detailed Description
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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.

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

Conditions
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Moderate Traumatic Brain Injury

Intervention / Treatment
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* Dietary Supplement: MLC901
* Genetic: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to receive either MLC901 or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MLC901 (NeuroAiD II)<br>This consists of extracts from 9 herbal components in a dark blue/light blue capsule | Dietary Supplement: MLC901<br>* This consists of extracts from 9 herbal components in a dark blue/light blue capsule<br>* Other names: NeuroAiD II;|
| Placebo Comparator: Placebo<br>This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule | Genetic: Placebo<br>* This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GOS-E at 6 months | This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 6 months | The number of patients who died in each arm at 6 months | 18 months | 
| Cerebral swelling at baseline, 1 & 2 weeks | Cerebral swelling is assessed by CT-scan | 18 months | 
| Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months | This clinical scale is the most widely used outcome measure after TBI, with the extended version scoring from 0 (dead) to full recovery (8). | 18 months | 
| Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months | This is a widely used clinical scale to assess the depth and duration of impaired consciousness and coma by measuring motor responsiveness, verbal performance and eye opening. The score ranges from 3 to 15. | 18 months | 
| Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months | This is an adaptation of the MoCA to the Philippine setting, used in the detection of mild cognitive impairment. The scores range between 0-10, with a score of 26 or over considered to be normal. | 18 months | 
| Frontal Assessment Battery at 1,3,6 & 9 monts | This battery of tests is used to assess frontal lobe dysfunction, consisting of the following sub tests: conceptualisation, mental flexibility, motor programming, sensitivity to interference, inhibitory control and environmental autonomy.Total scor is from a maximum of 18, with higher scores indicating better performance. | 18 months | 
| RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months | This is a 10 item questionnaire mainly used for patients with mild to moderate TBI. This is a 16 item questionnaire, scored on a 5 point Liberty scale ranging from 0 (not experienced at all) to 4 ( a severe problem). | 18 months | 
| Barthel Index (BI) at 1,3,6 & 9 months | This scale is used to assess functional disability by quantifying patient performance in 10 activities of daily living. The score ranges from 0 (totally dependent) to 100 (fully independent). | 18 months | 
| Hospital Anxiety and Depression Scale at 1,3,6 & 9 months | This scale is used to measure levels of anxiety and depression, ranging from 0 to 21,with normal score of 0-7, mild 8-10, moderate 11-14 and severe 15-21. | 18 months | 
| EQ-5D at 1,3,6 & 9 months (EuroQol Group) | This instrument describes the health status of respondents in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from 0-100, with higher scores for higher health related quality of life. | 18 months | 
| Safety until 9 months: adverse events | Safety is assessed by checking for the occurence of adverse events | 18 months | 
| Compliance until 6 months | Compliance is documented by the number of medications taken at set intervals during follow up | 18 months |