ANDROMEDA: MLC901 in Moderate Traumatic Brain Injury
Study Details
Study Description
Brief Summary
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: MLC901 (NeuroAiD II) This consists of extracts from 9 herbal components in a dark blue/light blue capsule |
Dietary Supplement: MLC901
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Other Names:
|
| Placebo Comparator: Placebo This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule |
Genetic: Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
|
Outcome Measures
Primary Outcome Measures
- GOS-E at 6 months [18 months]
This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery)
Secondary Outcome Measures
- Mortality at 6 months [18 months]
The number of patients who died in each arm at 6 months
- Cerebral swelling at baseline, 1 & 2 weeks [18 months]
Cerebral swelling is assessed by CT-scan
- Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months [18 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).
- Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months [18 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.
- Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months [18 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.
- Frontal Assessment Battery at 1,3,6 & 9 monts [18 months]
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.
- RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months [18 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).
- Barthel Index (BI) at 1,3,6 & 9 months [18 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).
- Hospital Anxiety and Depression Scale at 1,3,6 & 9 months [18 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.
- EQ-5D at 1,3,6 & 9 months (EuroQol Group) [18 months]
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.
- Safety until 9 months: adverse events [18 months]
Safety is assessed by checking for the occurence of adverse events
- Compliance until 6 months [18 months]
Compliance is documented by the number of medications taken at set intervals during follow up
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mariano Marcos Memorial Hospital and Medical Center | Batac | Ilocos Norte | Philippines | |
| 2 | Northern Mindanao Medical Center | Cagayan De Oro | Misamis Oriental | Philippines | 9000 |
| 3 | Philippine General Hospital | Manila | Philippines | 1000 |
Sponsors and Collaborators
- University of the Philippines
Investigators
- Principal Investigator: Annabell E Chua, MD, University of the Philippines Manila - Philippine General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJREB-2020-94