A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of MLC1501 in Patients With Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 11
- 主要终点
- Fugl-Meyer motor Assessment (FMA)
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled trial of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 high-dose twice a day, MLC1501 low-dose twice a day, or matching placebo for 24 weeks.
详细描述
A total of 300 patients will be included with approximately 100 patients randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: country, National Institute of Health Stroke Scale (NIHSS) (8 to 12, 13 to 18) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes).
Efficacy clinical assessments will include Fugl-Meyer motor Assessment (FMA), modified Rankin Scale (mRS), Patient Reported outcome Measurement Information System - Global Health (PROMIS-10) and NIHSS.
Each patient 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •≥18 years old or legal age as per country requirement
- •Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 10 days (inclusive) prior to inclusion.
- •NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 3 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.
排除标准
- •Pre-stroke modified Rankin score of >
- •Contraindication to any of the study procedures.
- •Patients who became medically unstable within 24 hours after intravenous or endovascular thrombolysis or thrombectomy.
- •Intake of any herbal or traditional medicine within the past 30 days.
- •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 or wish to continue breastfeeding while in the study. Women of child-bearing potential may be included if they agree to strict abstinence or use of effective contraception, except systemically acting hormonal contraceptives. Hormone replacement therapy in menopausal/post-menopausal or surgically sterilized women is also not allowed while in the study.
- •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.
研究组 & 干预措施
Placebo
500-mg placebo capsule, 4 capsules twice a day for 24 weeks
干预措施: Placebo (Other)
MLC1501 Low-dose
MLC1501 low-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
干预措施: MLC1501 (Drug)
MLC1501 High-dose
MLC1501 high-dose 500-mg capsule, 4 capsules twice a day for 24 weeks
干预措施: MLC1501 (Drug)
结局指标
主要结局
Fugl-Meyer motor Assessment (FMA)
时间窗: 24 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
次要结局
- Fugl-Meyer motor Assessment (FMA)(12 and 24 weeks)
- modified Rankin Scale (mRS)(4, 12 and 24 weeks)
- Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)(4, 12 and 24 weeks)
- Adverse events(up to 24 weeks)
- National Institute of Health Stroke Scale (NIHSS)(12 and 24 weeks)