Back to resultsMLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits (MAESTOSO)
Primary Purpose
Stroke, Stroke, Ischemic, Strokes Thrombotic
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
MLC1501
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, MLC1501, MAESTOSO, stroke recovery, neurorestoration
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.
Sites / Locations
- Baguio General Hospital and Medical CenterRecruiting
- West Visayas State University Medical CenterRecruiting
- Jose R. Reyes Memorial Medical CenterRecruiting
- Manila Doctors HospitaRecruiting
- Raffles HospitalRecruiting
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
MLC1501 Low-dose
MLC1501 High-dose
Arm Description
500-mg placebo capsule, 4 capsules twice a day for 24 weeks
MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
Fugl-Meyer motor Assessment (FMA)
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.
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.
National Institute of Health Stroke Scale (NIHSS)
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289947
Brief Title
MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits
Acronym
MAESTOSO
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moleac Pte Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Strokes Thrombotic, Stroke Sequelae, Stroke, Cardiovascular, Stroke, Embolic, Stroke, Cryptogenic
Keywords
stroke, MLC1501, MAESTOSO, stroke recovery, neurorestoration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500-mg placebo capsule, 4 capsules twice a day for 24 weeks
Arm Title
MLC1501 Low-dose
Arm Type
Active Comparator
Arm Description
MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
Arm Title
MLC1501 High-dose
Arm Type
Active Comparator
Arm Description
MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Caramel, chocolate brown, flavor (E_1982648), dextrin
Intervention Type
Drug
Intervention Name(s)
MLC1501
Intervention Description
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
Primary Outcome Measure Information:
Title
Fugl-Meyer motor Assessment (FMA)
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
Time Frame
up to 24 weeks
Title
Fugl-Meyer motor Assessment (FMA)
Time Frame
12 and 24 weeks
Title
modified Rankin Scale (mRS)
Description
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.
Time Frame
4, 12 and 24 weeks
Title
Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
Description
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.
Time Frame
4, 12 and 24 weeks
Title
National Institute of Health Stroke Scale (NIHSS)
Description
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Cheng
Phone
+65 6211 3710
Email
irene.cheng@moleac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert N Gan, MD
Phone
+65 6211 3710
Email
robert.gan@moleac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Chen, BMBCh, MRCP, FAMS, FRCPE
Organizational Affiliation
Departments of Pharmacology and Psychological Medicine, National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baguio General Hospital and Medical Center
City
Baguio
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Harold B Hiyadan
Facility Name
West Visayas State University Medical Center
City
Iloilo City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Advincula
Facility Name
Jose R. Reyes Memorial Medical Center
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus G. Escabillas
Facility Name
Manila Doctors Hospita
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Epifania V Collantes
Facility Name
Raffles Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narayanaswamy Venketasubramanian Ramani
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deidre Anne De Silva
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
Learn more about this trial
MLC1501 Study Assessing Efficacy in Post STrOke Subjects With mOtor Deficits
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