Moderate Traumatic Brain InjuryPhase 4ANDROMEDANCT04766281
MLC901 in Moderate Traumatic Brain Injury
A Phase 4 study testing MLC901 in people with Moderate Traumatic Brain Injury, run by University of the Philippines at 3 sites in Philippines.
Trial summary
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate Traumatic Brain Injury
- What is being tested?
- MLC901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesPhilippines
- Study dates
- 1 May 2021to 31 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites, 3 recruiting
- Recruiting
Mariano Marcos Memorial Hospital and Medical Center
Batac, Ilocos Norte
Tercy Manalo, M.D., terc81@yahoo.com
- Recruiting
Northern Mindanao Medical Center
Cagayan de Oro, Misamis Oriental, 9000
Vilma Yacapin, M.D., Penfield100370@yahoo.com.ph
- Recruiting
Philippine General Hospital
Manila, 1000
Annabell E Chua, M.D., 0285242338, aechua@up.edu.ph
About this study
Official title: Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
Read the 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.
- Conditions
- Moderate Traumatic Brain Injury
- Being tested
- MLC901, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC901Dietary supplement
Also called NeuroAiD II
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
PlaceboGenetic
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
| Study group | Role | What they receive |
|---|---|---|
| MLC901 (NeuroAiD II) | Active comparator | This consists of extracts from 9 herbal components in a dark blue/light blue capsule Receives: Dietary Supplement: MLC901 |
| Placebo | Placebo comparator | This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule Receives: Genetic: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (12)
Mortality at 6 months
The number of patients who died in each arm at 6 months
Measured: 18 months
Cerebral swelling at baseline, 1 & 2 weeks
Cerebral swelling is assessed by CT-scan
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 18 months
Safety until 9 months: adverse events
Safety is assessed by checking for the occurence of adverse events
Measured: 18 months
Compliance until 6 months
Compliance is documented by the number of medications taken at set intervals during follow up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 May 2021
- Primary completion30 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to receive either MLC901 or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annabell Chua, University of the Philippines
- Investigators
- Annabell E Chua, MD, Principal investigator, University of the Philippines Manila - Philippine General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766281
- Sponsor's protocol ID
- SJREB-2020-94
- Acronym
- ANDROMEDA
- Status last verified
- Jun 2023
- First submitted
- 5 Feb 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chua AE, Yacapin VJ, Manalo GL 3rd, Ledesma LK. Protocol for Safety and Efficacy of MLC901 (NeuroAiD II) in Patients With Moderate Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Trial (ANDROMEDA). Neurosurgery. 2023 Oct 1;93(4):939-951. doi: 10.1227/neu.0000000000002512. Epub 2023 May 2.
PubMed 37129384
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04766281
- Acronym / sponsor ID
- ANDROMEDA / SJREB-2020-94
- Conditions
- Moderate Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to receive either MLC901 or placebo
| Arm | Type | Receives |
|---|---|---|
| MLC901 (NeuroAiD II) | Active comparator | Dietary Supplement: MLC901This consists of extracts from 9 herbal components in a dark blue/light blue capsule |
| Placebo | Placebo comparator | Genetic: PlaceboThis consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLC901Also: NeuroAiD IIThis consists of extracts from 9 herbal components in a dark blue/light blue capsule | Dietary supplement | MLC901 (NeuroAiD II) |
| PlaceboThis consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule | Genetic | Placebo |
Primary outcome
GOS-E at 6 months
Time frame: 18 months
This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery)
12 secondary outcomes
Mortality at 6 months
Time frame: 18 months
Cerebral swelling at baseline, 1 & 2 weeks
Time frame: 18 months
Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months
Time frame: 18 months
Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months
Time frame: 18 months
Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months
Time frame: 18 months
Frontal Assessment Battery at 1,3,6 & 9 monts
Time frame: 18 months
RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months
Time frame: 18 months
Barthel Index (BI) at 1,3,6 & 9 months
Time frame: 18 months
Hospital Anxiety and Depression Scale at 1,3,6 & 9 months
Time frame: 18 months
EQ-5D at 1,3,6 & 9 months (EuroQol Group)
Time frame: 18 months
Safety until 9 months: adverse events
Time frame: 18 months
Compliance until 6 months
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 37129384Chua AE, Yacapin VJ, Manalo GL 3rd, Ledesma LK. Protocol for Safety and Efficacy of MLC901 (NeuroAiD II) in Patients With Moderate Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Trial (ANDROMEDA). Neurosurgery. 2023 Oct 1;93(4):939-951. doi: 10.1227/neu.0000000000002512. Epub 2023 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annabell E Chua, MD principal investigator
University of the Philippines Manila - Philippine General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MLC901 in people with Moderate Traumatic Brain Injury, run by University of the Philippines at 3 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annabell E Chua, MD (+632-85242338, aechua@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOS-E at 6 months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.