A Randomized, Controlled Study Evaluating the Efficacy and Safety of MLC901 (NeuroAiD™ II) in Patients With Mild to Moderate Ischemic Stroke.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)
研究概览
简要总结
This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.
详细描述
A total of 80 patients will be included, with approximately 40 patients randomized to each treatment group.
Group 1: Participants will receive MLC901 (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol.
Group 2: Participants will receive standard treatment according to the protocol.
The treatment period will last for 12 weeks. An optional follow-up visit at Week 24 may be conducted to assess the durability of the treatment effect.
Efficacy assessments will include the EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4), Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), muscle strength assessment, and MRI-based assessment of cerebral infarct volume.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Aged 18 to 80 years, inclusive.
- •Diagnosed with ischemic stroke, with brain imaging findings consistent with the diagnosis, and enrolled 2-10 days after stroke onset.
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score of 1-15 at the time of screening.
- •Clinically stable at the time of enrollment.
- •Considered by the treating physician to be a suitable candidate for active rehabilitation.
- •Able to comply with the requirements of the study protocol and has provided written informed consent to participate in the study, either personally or through a legally authorized representative, as applicable, before any study-specific procedures are performed.
排除标准
- •Other neurological or psychiatric disorders that may interfere with study assessments, including:
- •Hemorrhagic stroke.
- •Evidence of other significant non-ischemic brain lesions that may affect long-term functional outcomes or disability.
- •Evidence of progressive medical conditions that may interfere with study assessments or follow-up (e.g., cancer, kidney failure, liver cirrhosis, severe dementia, or psychiatric disorders).
- •Any medical, psychiatric, or cognitive condition that, in the investigator's opinion, may place the participant at risk during study participation, interfere with the conduct of study procedures, compromise study follow- up, or confound the study results.
- •Contraindication to any study procedure.
- •Clinically unstable condition within 24 hours after thrombolysis (intravenous/endovascular) or thrombectomy.
- •Use of Cerebrolysin, piracetam, erythropoietin, edaravone, or vinpocetine within 30 days prior to enrollment.
- •Current use of finished medicinal products or herbal medicinal products containing ingredients that overlap with any component of MLC
- •Participation in another investigational drug or medical device trial within 30 days prior to enrollment.
- •Pregnancy or breastfeeding. Women of childbearing potential are eligible only if they commit to complete abstinence from sexual intercourse or use effective contraception (excluding systemic hormonal contraceptives). Participants receiving hormone replacement therapy are not eligible (this applies to premenopausal, postmenopausal, or surgically sterilized women).
- •History of food allergy or hypersensitivity to any component of MLC901
研究组 & 干预措施
MLC901 (NeuroAiD™ II) + Standard Treatment
Participants will receive MLC901 (NeuroAiD™ II) (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol for 12 weeks.
干预措施: Standard treatment for acute ischemic stroke (Other)
Standard Treatment
Participants will receive standard treatment according to the protocol for 12 weeks.
干预措施: Standard treatment for acute ischemic stroke (Other)
MLC901 (NeuroAiD™ II) + Standard Treatment
Participants will receive MLC901 (NeuroAiD™ II) (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol for 12 weeks.
干预措施: MLC901 (Drug)
结局指标
主要结局
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
时间窗: Baseline, Day 7 and Day 14
The EQ-5D-5L is a patient-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of response.
EuroQol Visual Analogue Scale (EQ-VAS)
时间窗: Baseline, Day 7 and Day 14
The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine.
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4)
时间窗: Baseline, Day 7 and Day 14
The TSQM-1.4 is a patient-reported questionnaire used to assess treatment satisfaction across the domains of effectiveness, side effects, convenience, and global satisfaction.
Adverse Events
时间窗: From baseline through Week 12, and at the optional Week 24 follow-up visit.
Frequency, incidence rate, and severity of adverse events during the study period.
Hemorrhagic Complications
时间窗: From baseline through Week 12, and at the optional Week 24 follow-up visit.
Presence or absence of hemorrhagic complications during the study period.
次要结局
- Modified Rankin Scale (mRS)(Baseline, Week 4 and Week 12)
- Fugl-Meyer Assessment (FMA)(Baseline, Day 14, Week 4 and Week 12)
- National Institutes of Health Stroke Scale (NIHSS)(Baseline, Day 14 and Week 12)
- Maximum Muscle Strength(Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12)
- Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)(Baseline and Week 12 (±7 days))