A Phase 4 interventional study of MLC901 and Placebo in Moderate Traumatic Brain Injury, sponsored by University of the Philippines. Recruiting at 3 sites in Philippines. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by University of the Philippines · Phase 4, Interventional, and Treatment
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Dietary Supplement: MLC901
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Genetic: Placebo
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Also known as: NeuroAiD II
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
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)
Time frame: 18 months
Mortality at 6 months
The number of patients who died in each arm at 6 months
Time frame: 18 months
Cerebral swelling at baseline, 1 & 2 weeks
Cerebral swelling is assessed by CT-scan
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Safety until 9 months: adverse events
Safety is assessed by checking for the occurence of adverse events
Time frame: 18 months
Compliance until 6 months
Compliance is documented by the number of medications taken at set intervals during follow up
Time frame: 18 months
Started May 2021 (actual). Primary completion is estimated for May 2024, 36 months after the start.
Of 25 phase 4 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 148. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Neuroaid
University of the Philippines