MLC1501 Study Assessing Efficacy in STROke Recovery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• modified Rankin Scale [Срок оценки: 24 weeks]

Вторичные конечные точки (12)

• Fugl-Meyer motor Assessment (FMA) [Срок оценки: 12, 24 weeks]
• Action Research Arm Test (ARAT) [Срок оценки: 12, 24 weeks]
• Timed 10-Meter Walk Test (10MWT) [Срок оценки: 12, 24 weeks]
• National Institute of Health Stroke Scale total and motor scores [Срок оценки: 12, 24 weeks]
• Barthel Index [Срок оценки: 4, 12, 24, 36 weeks]
• EuroQol 5 Dimensions 5 Levels [Срок оценки: 4, 12, 24, 36 weeks]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: 12, 24 weeks]
• Occurrence of recurrent vascular event [Срок оценки: 24, 36 weeks]
• Patient Reported Outcome Measurement Information System - Global Health [Срок оценки: 12, 24 weeks]
• Columbia-Suicide Severity Rating Scale screen [Срок оценки: 4, 12, 24, 36 weeks]
• Adverse events [Срок оценки: up to 36 weeks]
• modified Rankin Scale [Срок оценки: 4, 12 and 36 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05046106 · EFSA2019_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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