MLC1501 Study Assessing Efficacy in STROke Recovery

NCT05046106 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EFSA2019_01
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-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; MAEStro; stroke recovery; neurorestoration

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale

  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.

  24 weeks

Secondary Outcomes (12)

• Fugl-Meyer motor Assessment (FMA)

  12, 24 weeks

• Action Research Arm Test (ARAT)

  12, 24 weeks

• Timed 10-Meter Walk Test (10MWT)

  12, 24 weeks

• National Institute of Health Stroke Scale total and motor scores

  12, 24 weeks

• Barthel Index

  4, 12, 24, 36 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

MLC1501 DRUG

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

MLC1501 High-dose; MLC1501 Low-dose

Placebo OTHER

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

Placebo

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.
• years old or older.
• 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.
• 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, breastfeeding, of child-bearing potential or planning to become pregnant during the study. Menopausal/post-menopausal women without menstruation for 12 consecutive months or surgically sterilized women may be included. Intake of oral contraceptive pills or hormone replacement therapy is not allowed. Use of mechanical barriers, e.g., condom, intrauterine device, are allowed. Local contraception requirements for clinical trials should be followed.
• 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

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

Central Study Contacts

Emily Lim

CONTACT

+65 62113710; emily.lim@moleac.com

Robert N Gan, MD

CONTACT

+65 62113710; robert.gan@moleac.com

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: September 2, 2021
• First Posted: September 16, 2021
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 16, 2023

Record last verified: 2023-03