MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits

NCT05289947 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: EFSA2021_01
• Study Type: interventional
• Target: 303
• Locations: 2 countries
• Sites: 11

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.

Conditions

Stroke; Stroke, Ischemic; Strokes Thrombotic; Stroke Sequelae; Stroke, Cardiovascular; Stroke, Embolic; Stroke, Cryptogenic

Keywords

stroke; MLC1501; MAESTOSO; stroke recovery; neurorestoration

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Secondary Outcomes (5)

• Adverse events

  up to 24 weeks

• Fugl-Meyer motor Assessment (FMA)

  12 and 24 weeks

• modified Rankin Scale (mRS)

  4, 12 and 24 weeks

• Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)

  4, 12 and 24 weeks

• National Institute of Health Stroke Scale (NIHSS)

  12 and 24 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

MLC1501 Low-dose

ACTIVE COMPARATOR

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

Drug: MLC1501

MLC1501 High-dose

ACTIVE COMPARATOR

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

Drug: MLC1501

Interventions

Placebo OTHER

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

Placebo

MLC1501 DRUG

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

MLC1501 High-dose; MLC1501 Low-dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• ≥18 years old or legal age as per country requirement
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moleac Pte Ltd.: lead

Study Sites (11)

Metro Davao Medical And Research Center

Davao City, Davao Region, Philippines

Location

Quirino Memorial Medical Center

Manila, Manila, Philippines

Location

University of Santo Tomas Hospital

Manila, Manila, Philippines

Location

Baguio General Hospital and Medical Center

Baguio City, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Philippines

Location

Jose R. Reyes Memorial Medical Center

Manila, Philippines

Location

Manila Doctors Hospita

Manila, Philippines

Location

Changi General Hospital

Singapore, Singapore, Singapore

Location

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

Singapore, Singapore, Singapore

Location

Raffles Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 39915229 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Thrombotic Stroke; Myocardial Infarction; Embolic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Christopher Chen, BMBCh, MRCP, FAMS, FRCPE

  Departments of Pharmacology and Psychological Medicine, National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: July 21, 2023
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

PH (7); SG (4)