MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits (MAESTOSO)

September 22, 2023 updated by: Moleac Pte Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Philippines
      • Baguio, Philippines
        • Recruiting
        • Baguio General Hospital and Medical Center
        • Contact:
          • John Harold B Hiyadan
      • Iloilo City, Philippines
        • Recruiting
        • West Visayas State University Medical Center
        • Contact:
          • Joel Advincula
      • Manila, Philippines
        • Recruiting
        • Jose R. Reyes Memorial Medical Center
        • Contact:
          • Cyrus G. Escabillas
      • Manila, Philippines
        • Recruiting
        • Manila Doctors Hospita
        • Contact:
          • Maria Epifania V Collantes
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Deidre Anne De Silva
      • Singapore, Singapore
        • Recruiting
        • Raffles Hospital
        • Contact:
          • Narayanaswamy Venketasubramanian Ramani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
500-mg placebo capsule, 4 capsules twice a day for 24 weeks
Other: Placebo
Caramel, chocolate brown, flavor (E_1982648), dextrin
Active Comparator: MLC1501 Low-dose
MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
Drug: MLC1501
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
Active Comparator: MLC1501 High-dose
MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
Drug: MLC1501
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 24 weeks
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
up to 24 weeks
Fugl-Meyer motor Assessment (FMA)
Time Frame: 12 and 24 weeks
12 and 24 weeks
modified Rankin Scale (mRS)
Time Frame: 4, 12 and 24 weeks
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.
4, 12 and 24 weeks
Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
Time Frame: 4, 12 and 24 weeks
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.
4, 12 and 24 weeks
National Institute of Health Stroke Scale (NIHSS)
Time Frame: 12 and 24 weeks
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moleac Pte Ltd.

Investigators

  • Principal Investigator: Christopher Chen, BMBCh, MRCP, FAMS, FRCPE, Departments of Pharmacology and Psychological Medicine, National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFSA2021_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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