StrokePhase 2/3MAEStroNCT05046106
MLC1501 Study Assessing Efficacy in STROke Recovery
A Phase 2/3 study testing MLC1501 in people with Stroke and Stroke, Ischemic, run by Moleac Pte Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Strokes Thrombotic
- What is being tested?
- MLC1501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke
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.
Read the 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.
- Conditions
- Stroke, Stroke, Ischemic, Strokes Thrombotic, Stroke Sequelae, Stroke, Cardiovascular, Stroke, Embolic
- Being tested
- MLC1501, Placebo
- Keywords
- stroke, MLC1501, MAEStro, stroke recovery, neurorestoration
- Medical subject headings
- Stroke, Ischemic Stroke, Thrombotic Stroke, Myocardial Infarction, Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC1501Drug
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
PlaceboOther
Caramel, chocolate brown, flavor (E_1982648), dextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 500-mg placebo capsule, 4 capsules twice a day for 24 weeks. Receives: Other: Placebo |
| MLC1501 Low-dose | Active comparator | MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks. Receives: Drug: MLC1501 |
| MLC1501 High-dose | Active comparator | MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks. Receives: Drug: MLC1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (12)
Fugl-Meyer motor Assessment (FMA)
Measured: 12, 24 weeks
Action Research Arm Test (ARAT)
Measured: 12, 24 weeks
Timed 10-Meter Walk Test (10MWT)
Measured: 12, 24 weeks
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)
Measured: 12, 24 weeks
Barthel Index
Measured: 4, 12, 24, 36 weeks
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
Measured: 4, 12, 24, 36 weeks
Montreal Cognitive Assessment (MoCA)
Measured: 12, 24 weeks
Occurrence of recurrent vascular event
Measured: 24, 36 weeks
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.
Measured: 12, 24 weeks
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)
Measured: 4, 12, 24, 36 weeks
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
Measured: up to 36 weeks
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.
Measured: 4, 12 and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study startJan 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Chen, BMBCh, MRCP, FAMS, FRCPE, Principal investigator, Departments of Pharmacology and Psychological Medicine, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046106
- Sponsor's protocol ID
- EFSA2019_01
- Acronym
- MAEStro
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05046106
- Acronym / sponsor ID
- MAEStro / EFSA2019_01
- Conditions
- Stroke, Stroke, Ischemic, Strokes Thrombotic, Stroke Sequelae, Stroke, Cardiovascular, Stroke, Embolic
- Keywords
- stroke, MLC1501, MAEStro, stroke recovery, neurorestoration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo500-mg placebo capsule, 4 capsules twice a day for 24 weeks. |
| MLC1501 Low-dose | Active comparator | Drug: MLC1501MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks. |
| MLC1501 High-dose | Active comparator | Drug: MLC1501MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLC1501Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala | Drug | MLC1501 High-dose, MLC1501 Low-dose |
| PlaceboCaramel, chocolate brown, flavor (E_1982648), dextrin | Other | Placebo |
Primary outcome
modified Rankin Scale
Time frame: 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.
12 secondary outcomes
Fugl-Meyer motor Assessment (FMA)
Time frame: 12, 24 weeks
Action Research Arm Test (ARAT)
Time frame: 12, 24 weeks
Timed 10-Meter Walk Test (10MWT)
Time frame: 12, 24 weeks
National Institute of Health Stroke Scale total and motor scores
Time frame: 12, 24 weeks
Barthel Index
Time frame: 4, 12, 24, 36 weeks
EuroQol 5 Dimensions 5 Levels
Time frame: 4, 12, 24, 36 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 12, 24 weeks
Occurrence of recurrent vascular event
Time frame: 24, 36 weeks
Patient Reported Outcome Measurement Information System - Global Health
Time frame: 12, 24 weeks
Columbia-Suicide Severity Rating Scale screen
Time frame: 4, 12, 24, 36 weeks
Adverse events
Time frame: up to 36 weeks
modified Rankin Scale
Time frame: 4, 12 and 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided. Once decided, only anonymized IPD may be shared with other collaborative stroke trials consortiums.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Chen, BMBCh, MRCP, FAMS, FRCPE principal investigator
Departments of Pharmacology and Psychological Medicine, National University of Singapore
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MLC1501 in people with Stroke and Stroke, Ischemic, run by Moleac Pte Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Lim (+65 62113710 ext. 184, emily.lim@moleac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.