MLC1501 Study Assessing Efficacy in STROke Recovery

Stroke Clinical Trial

— MAEStro  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05046106
• Other study ID #: EFSA2019_01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2025
• Est. completion date: December 2028

Study information

• Verified date: March 2023
• Source: Moleac Pte Ltd.
• Contact: Emily Lim
• Phone: +65 62113710
• Email: emily.lim[@]moleac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: December 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke
• Ischemic Stroke
• Myocardial Infarction
• Stroke
• Stroke Sequelae
• Stroke, Cardiovascular
• Stroke, Ischemic
• Strokes Thrombotic
• Thrombotic Stroke

Intervention

Drug:
• MLC1501
Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala

Other:
• Placebo
Caramel, chocolate brown, flavor (E_1982648), dextrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moleac Pte Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fugl-Meyer motor Assessment (FMA)		12, 24 weeks
Secondary	Action Research Arm Test (ARAT)		12, 24 weeks
Secondary	Timed 10-Meter Walk Test (10MWT)		12, 24 weeks
Secondary	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)	12, 24 weeks
Secondary	Barthel Index		4, 12, 24, 36 weeks
Secondary	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	4, 12, 24, 36 weeks
Secondary	Montreal Cognitive Assessment (MoCA)		12, 24 weeks
Secondary	Occurrence of recurrent vascular event		24, 36 weeks
Secondary	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.	12, 24 weeks
Secondary	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)	4, 12, 24, 36 weeks
Secondary	Adverse events	Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort	up to 36 weeks
Secondary	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.	4, 12 and 36 weeks