MLC1501 Study Assessing Efficacy in STROke Recovery

Official title

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

Overview

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.

Interventions

• Drug MLC1501
  Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
• Other Placebo
  Caramel, chocolate brown, flavor (E\_1982648), dextrin

Primary outcome measures

• modified Rankin Scale [Time frame: 24 weeks]

Secondary outcome measures (12)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05046106 · EFSA2019_01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗