MLC901 in Moderate Traumatic Brain Injury (ANDROMEDA)
Primary Purpose
Moderate Traumatic Brain Injury
Status
Recruiting
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
MLC901
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Mariano Marcos Memorial Hospital and Medical CenterRecruiting
- Northern Mindanao Medical CenterRecruiting
- Philippine General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MLC901 (NeuroAiD II)
Placebo
Arm Description
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Mortality at 6 months
The number of patients who died in each arm at 6 months
Cerebral swelling at baseline, 1 & 2 weeks
Cerebral swelling is assessed by CT-scan
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).
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.
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.
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.
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).
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).
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.
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.
Safety until 9 months: adverse events
Safety is assessed by checking for the occurence of adverse events
Compliance until 6 months
Compliance is documented by the number of medications taken at set intervals during follow up
Full Information
NCT ID
NCT04766281
First Posted
February 5, 2021
Last Updated
June 11, 2023
Sponsor
University of the Philippines
1. Study Identification
Unique Protocol Identification Number
NCT04766281
Brief Title
MLC901 in Moderate Traumatic Brain Injury
Acronym
ANDROMEDA
Official Title
Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Philippines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to receive either MLC901 or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MLC901 (NeuroAiD II)
Arm Type
Active Comparator
Arm Description
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
MLC901
Other Intervention Name(s)
NeuroAiD II
Intervention Description
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Intervention Type
Genetic
Intervention Name(s)
Placebo
Intervention Description
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Primary Outcome Measure Information:
Title
GOS-E at 6 months
Description
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
Secondary Outcome Measure Information:
Title
Mortality at 6 months
Description
The number of patients who died in each arm at 6 months
Time Frame
18 months
Title
Cerebral swelling at baseline, 1 & 2 weeks
Description
Cerebral swelling is assessed by CT-scan
Time Frame
18 months
Title
Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months
Description
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
Title
Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months
Description
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
Title
Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months
Description
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
Title
Frontal Assessment Battery at 1,3,6 & 9 monts
Description
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
Title
RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months
Description
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
Title
Barthel Index (BI) at 1,3,6 & 9 months
Description
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
Title
Hospital Anxiety and Depression Scale at 1,3,6 & 9 months
Description
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
Title
EQ-5D at 1,3,6 & 9 months (EuroQol Group)
Description
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
Title
Safety until 9 months: adverse events
Description
Safety is assessed by checking for the occurence of adverse events
Time Frame
18 months
Title
Compliance until 6 months
Description
Compliance is documented by the number of medications taken at set intervals during follow up
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annabell E Chua, MD
Phone
+632-85242338
Email
aechua@up.edu.ph
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annabell E Chua, MD
Organizational Affiliation
University of the Philippines Manila - Philippine General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariano Marcos Memorial Hospital and Medical Center
City
Batac
State/Province
Ilocos Norte
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tercy Manalo, M.D.
Email
terc81@yahoo.com
Facility Name
Northern Mindanao Medical Center
City
Cagayan De Oro
State/Province
Misamis Oriental
ZIP/Postal Code
9000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilma Yacapin, M.D.
Email
Penfield100370@yahoo.com.ph
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annabell E Chua, M.D.
Phone
0285242338
Email
aechua@up.edu.ph
12. IPD Sharing Statement
Learn more about this trial
MLC901 in Moderate Traumatic Brain Injury
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