StrokePhase 2MAESTOSONCT05289947
MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits
A Phase 2 study testing MLC1501 in people with Stroke and Stroke, Ischemic, run by Moleac Pte Ltd. at 11 sites in 2 countries.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Strokes Thrombotic
- What is being tested?
- MLC1501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 21 Jul 2023to 18 Jul 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- ≥18 years old or legal age as per country requirement
- Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 10 days (inclusive) prior to inclusion.
- NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 3 on the NIHSS motor items 5A or 5B and/or 6A or 6B.
- A candidate for active rehabilitation in the opinion of the treating physician.
- Able to comply with the requirements of the protocol and provide written informed consent by patient or legal representative before any study-specific procedure is performed.
Who cannot join
- Pre-stroke modified Rankin score of >1.
- Contraindication to any of the study procedures.
- Patients who became medically unstable within 24 hours after intravenous or endovascular thrombolysis or thrombectomy.
- Intake of any herbal or traditional medicine within the past 30 days.
- Participation in another investigational drug or device trial within the past 30 days.
- Intake of warfarin in the past one week or expected to be on warfarin while in the study.
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- Women who are pregnant or wish to continue breastfeeding while in the study. Women of child-bearing potential may be included if they agree to strict abstinence or use of effective contraception, except systemically acting hormonal contraceptives. Hormone replacement therapy in menopausal/post-menopausal or surgically sterilized women is also not allowed while in the study.
- Any known food allergy or hypersensitivity to Astragalus membranaceus, Ligusticum chuanxiong, Polygala tenuifolia, Angelica sinensis, or members of the Fabaceae/Leguminosae family (e.g., legume, pea, bean), Polygalaceae family (e.g., milkwort, snakeroot), Apiaceae/Umbelliferae family (e.g., anise, caraway, carrot, celery, dill, parsley, parsnip), or Quillaja bark (soapbark).
- Evidence of other significant non-ischemic brain lesion which could affect long-term function or disability.
- Evidence of advanced medical condition that would affect study assessment and follow-up, such as cancer, renal failure, liver cirrhosis, severe dementia, or psychosis.
- Any other medical or psychiatric or cognitive condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study, may hamper his/her ability to complete procedures required in the study, affect study assessment and follow-up, or affect the validity of the study results.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Philippines7 sites
Baguio General Hospital and Medical Center
Baguio City
Metro Davao Medical And Research Center
Davao City, Davao Region
West Visayas State University Medical Center
Iloilo City
Quirino Memorial Medical Center
Manila, Manila
University of Santo Tomas Hospital
Manila, Manila
Jose R. Reyes Memorial Medical Center
Manila
Manila Doctors Hospita
Manila
Singapore4 sites
Changi General Hospital
Singapore, Singapore
National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)
Singapore, Singapore
Raffles Hospital
Singapore
Singapore General Hospital
Singapore
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke
This is a multi-center, randomized, double-blind, placebo-controlled trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks.
Read the detailed description
A total of 300 patients will be included with approximately 100 patients randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: country, National Institute of Health Stroke Scale (NIHSS) (8 to 12, 13 to 18) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes).
Efficacy clinical assessments will include Fugl-Meyer motor Assessment (FMA), modified Rankin Scale (mRS), Patient Reported outcome Measurement Information System - Global Health (PROMIS-10) and NIHSS.
Each patient will undergo standard safety assessments including physical exam and laboratory parameters, and be observed for adverse events for the duration of the study. Electrocardiogram (ECG), hematology, clinical chemistry, coagulation, and urinalysis will be performed at specified intervals.
- Conditions
- Stroke, Stroke, Ischemic, Strokes Thrombotic, Stroke Sequelae, Stroke, Cardiovascular, Stroke, Embolic
- Being tested
- Placebo, MLC1501
- Keywords
- stroke, MLC1501, MAESTOSO, stroke recovery, neurorestoration
- Medical subject headings
- Stroke, Ischemic Stroke, Thrombotic Stroke, Myocardial Infarction, Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Caramel, chocolate brown, flavor (E_1982648), dextrin
MLC1501Drug
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 500-mg placebo capsule, 4 capsules twice a day for 24 weeks Receives: Other: Placebo |
| MLC1501 Low-dose | Active comparator | MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks Receives: Drug: MLC1501 |
| MLC1501 High-dose | Active comparator | MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks Receives: Drug: MLC1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer motor Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Measured: 24 weeks
Secondary outcomes (5)
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
Measured: up to 24 weeks
Fugl-Meyer motor Assessment (FMA)
Measured: 12 and 24 weeks
modified Rankin Scale (mRS)
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who expire.
Measured: 4, 12 and 24 weeks
Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: 4, 12 and 24 weeks
National Institute of Health Stroke Scale (NIHSS)
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start21 Jul 2023
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
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 StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Chen, BMBCh, MRCP, FAMS, FRCPE, Principal investigator, Departments of Pharmacology and Psychological Medicine, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289947
- Sponsor's protocol ID
- EFSA2021_01
- Acronym
- MAESTOSO
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
Publications
Chen CPLH, Esagunde RU, Escabillas CG, Hiyadan JH, Advincula JM, Co COC, Collantes MEV, Lao AY, Koh YH, De Silva DA, Tham CH, Lokin JK, Venketasubramanian N. Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol. Stroke Vasc Neurol. 2025 Oct 27;10(5):657-664. doi: 10.1136/svn-2024-003750.
PubMed 39915229
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05289947
- Acronym / sponsor ID
- MAESTOSO / EFSA2021_01
- Conditions
- Stroke, Stroke, Ischemic, Strokes Thrombotic, Stroke Sequelae, Stroke, Cardiovascular, Stroke, Embolic
- Keywords
- stroke, MLC1501, MAESTOSO, stroke recovery, neurorestoration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 22 Mar 2022 (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 is a multi-center, randomized, double-blind, placebo-controlled trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks.
Detailed description
A total of 300 patients will be included with approximately 100 patients randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: country, National Institute of Health Stroke Scale (NIHSS) (8 to 12, 13 to 18) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes).
Efficacy clinical assessments will include Fugl-Meyer motor Assessment (FMA), modified Rankin Scale (mRS), Patient Reported outcome Measurement Information System - Global Health (PROMIS-10) and NIHSS.
Each patient will undergo standard safety assessments including physical exam and laboratory parameters, and be observed for adverse events for the duration of the study. Electrocardiogram (ECG), hematology, clinical chemistry, coagulation, and urinalysis will be performed at specified intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo500-mg placebo capsule, 4 capsules twice a day for 24 weeks |
| MLC1501 Low-dose | Active comparator | Drug: MLC1501MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks |
| MLC1501 High-dose | Active comparator | Drug: MLC1501MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female.
- ≥18 years old or legal age as per country requirement
- Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 10 days (inclusive) prior to inclusion.
- NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 3 on the NIHSS motor items 5A or 5B and/or 6A or 6B.
- A candidate for active rehabilitation in the opinion of the treating physician.
Key exclusion criteria (11 listed)
- Pre-stroke modified Rankin score of >1.
- Contraindication to any of the study procedures.
- Patients who became medically unstable within 24 hours after intravenous or endovascular thrombolysis or thrombectomy.
- Intake of any herbal or traditional medicine within the past 30 days.
- Participation in another investigational drug or device trial within the past 30 days.
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 |
|---|---|---|
| PlaceboCaramel, chocolate brown, flavor (E_1982648), dextrin | Other | Placebo |
| MLC1501Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala | Drug | MLC1501 High-dose, MLC1501 Low-dose |
Primary outcome
Fugl-Meyer motor Assessment (FMA)
Time frame: 24 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
5 secondary outcomes
Adverse events
Time frame: up to 24 weeks
Fugl-Meyer motor Assessment (FMA)
Time frame: 12 and 24 weeks
modified Rankin Scale (mRS)
Time frame: 4, 12 and 24 weeks
Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
Time frame: 4, 12 and 24 weeks
National Institute of Health Stroke Scale (NIHSS)
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 39915229Chen CPLH, Esagunde RU, Escabillas CG, Hiyadan JH, Advincula JM, Co COC, Collantes MEV, Lao AY, Koh YH, De Silva DA, Tham CH, Lokin JK, Venketasubramanian N. Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol. Stroke Vasc Neurol. 2025 Oct 27;10(5):657-664. doi: 10.1136/svn-2024-003750.
- Individual participant dataSharing planned: Undecided. Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
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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.
Christopher Chen, BMBCh, MRCP, FAMS, FRCPE principal investigator
Departments of Pharmacology and Psychological Medicine, National University of Singapore
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLC1501 in people with Stroke and Stroke, Ischemic, run by Moleac Pte Ltd. at 11 sites in 2 countries.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Philippines, Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer motor Assessment (FMA) (time frame: 24 weeks). 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 NCT05289947, 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 9 Dec 2025.