Back to resultsMLC1501 Study Assessing Efficacy in STROke Recovery (MAEStro)
Primary Purpose
Stroke, Stroke, Ischemic, Strokes Thrombotic
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MLC1501
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, MLC1501, MAEStro, stroke recovery, neurorestoration
Eligibility Criteria
Inclusion Criteria:
- Male or female.
- 18 years old or older.
- Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 7 days prior to inclusion. Patients who undergo intravenous or endovascular thrombolysis or thrombectomy must be considered stable for at least 24 hours post-procedure prior to inclusion.
- NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 2 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.
- 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
Sites / Locations
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
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.
Secondary Outcome Measures
Fugl-Meyer motor Assessment (FMA)
Action Research Arm Test (ARAT)
Timed 10-Meter Walk Test (10MWT)
National Institute of Health Stroke Scale total and motor scores
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Barthel Index
EuroQol 5 Dimensions 5 Levels
EQ5D-5L has 5 response levels: level 1 (no problems), 2 (slight), 3 (moderate), 4 (severe). Sometimes it is more convenient to dichotomies the levels into 'no problem's (level 1) and 'any problems' (level 2 to 5). In total, there are 3,125 possible unique health states defined by the EQ-5D-5L, with 11111 and 55555 representing the best and worst health states
Montreal Cognitive Assessment (MoCA)
Occurrence of recurrent vascular event
Patient Reported Outcome Measurement Information System - Global Health
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.
Columbia-Suicide Severity Rating Scale screen
There are no specified clinical cutoffs for the C-SSRS due to the binary nature of the responses to items. When an item is endorsed, the clinician must pose follow-up inquiries to obtain additional information. The following can inform safety monitoring and treatment planning when patients endorse suicidal ideation, suicidal behavior, or both:
Suicidal ideation (Item endorsement: Yes; C-SSRS Categories 1-5)
Suicidal behavior (Item endorsement: Yes; C-SSRS Categories 6-10)
Suicidal ideation & behavior (Item endorsement: Yes; C-SSRS Categories 1-10)
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05046106
Brief Title
MLC1501 Study Assessing Efficacy in STROke Recovery
Acronym
MAEStro
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2025 (Anticipated)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
December 2028 (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, 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.
Detailed Description
A total of 540 patients will be included with approximately 180 participants randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: NIHSS (8 to 12, 13 to 18), age (<65 years, ≥65 years) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes).
Efficacy clinical assessments will include mRS, FMA, ARAT, 10MWT, NIHSS, Barthel Index, EQ-5D-5L, MoCA, PROMIS-10, and occurrence of recurrent vascular event.
Each participant 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. The C-SSRS will be used to screen for suicidal ideation and behavior. Blood samples will be collected and stored for future studies on circulating compounds and pharmacokinetics.
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, MAEStro, stroke recovery, neurorestoration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (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
Drug
Intervention Name(s)
MLC1501
Intervention Description
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Caramel, chocolate brown, flavor (E_1982648), dextrin
Primary Outcome Measure Information:
Title
modified Rankin Scale
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
24 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer motor Assessment (FMA)
Time Frame
12, 24 weeks
Title
Action Research Arm Test (ARAT)
Time Frame
12, 24 weeks
Title
Timed 10-Meter Walk Test (10MWT)
Time Frame
12, 24 weeks
Title
National Institute of Health Stroke Scale total and motor scores
Description
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Time Frame
12, 24 weeks
Title
Barthel Index
Time Frame
4, 12, 24, 36 weeks
Title
EuroQol 5 Dimensions 5 Levels
Description
EQ5D-5L has 5 response levels: level 1 (no problems), 2 (slight), 3 (moderate), 4 (severe). Sometimes it is more convenient to dichotomies the levels into 'no problem's (level 1) and 'any problems' (level 2 to 5). In total, there are 3,125 possible unique health states defined by the EQ-5D-5L, with 11111 and 55555 representing the best and worst health states
Time Frame
4, 12, 24, 36 weeks
Title
Montreal Cognitive Assessment (MoCA)
Time Frame
12, 24 weeks
Title
Occurrence of recurrent vascular event
Time Frame
24, 36 weeks
Title
Patient Reported Outcome Measurement Information System - Global Health
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
12, 24 weeks
Title
Columbia-Suicide Severity Rating Scale screen
Description
There are no specified clinical cutoffs for the C-SSRS due to the binary nature of the responses to items. When an item is endorsed, the clinician must pose follow-up inquiries to obtain additional information. The following can inform safety monitoring and treatment planning when patients endorse suicidal ideation, suicidal behavior, or both:
Suicidal ideation (Item endorsement: Yes; C-SSRS Categories 1-5)
Suicidal behavior (Item endorsement: Yes; C-SSRS Categories 6-10)
Suicidal ideation & behavior (Item endorsement: Yes; C-SSRS Categories 1-10)
Time Frame
4, 12, 24, 36 weeks
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 36 weeks
Title
modified Rankin Scale
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 36 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 older.
Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 7 days prior to inclusion. Patients who undergo intravenous or endovascular thrombolysis or thrombectomy must be considered stable for at least 24 hours post-procedure prior to inclusion.
NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 2 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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lim
Phone
+65 62113710
Ext
184
Email
emily.lim@moleac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert N Gan, MD
Phone
+65 62113710
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
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 STROke Recovery
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