MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits

NCT ID: NCT05289947

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2025-07-18

Brief 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.

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; Stroke, Cryptogenic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

500-mg placebo capsule, 4 capsules twice a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Caramel, chocolate brown, flavor (E\_1982648), dextrin

MLC1501 Low-dose

MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks

Group Type: ACTIVE_COMPARATOR

MLC1501

Intervention Type: DRUG

Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

MLC1501 High-dose

MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks

Group Type: ACTIVE_COMPARATOR

MLC1501

Intervention Type: DRUG

Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

Interventions

Placebo

Caramel, chocolate brown, flavor (E\_1982648), dextrin

Intervention Type: OTHER

MLC1501

Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moleac Pte Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Chen, BMBCh, MRCP, FAMS, FRCPE

Role: PRINCIPAL_INVESTIGATOR

Departments of Pharmacology and Psychological Medicine, National University of Singapore

Locations

Metro Davao Medical And Research Center

Davao City, Davao Region, Philippines

Quirino Memorial Medical Center

Manila, Manila, Philippines

University of Santo Tomas Hospital

Manila, Manila, Philippines

Baguio General Hospital and Medical Center

Baguio City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

Jose R. Reyes Memorial Medical Center

Manila, , Philippines

Manila Doctors Hospita

Manila, , Philippines

Changi General Hospital

Singapore, Singapore, Singapore

National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)

Singapore, Singapore, Singapore

Raffles Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Philippines; Singapore

References

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.

Reference Type: DERIVED

PMID: 39915229 (View on PubMed)

Other Identifiers

EFSA2021_01

Identifier Type: -

Identifier Source: org_study_id