💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Aged 18 to 80 years, inclusive.
2. Diagnosed with ischemic stroke, with brain imaging findings consistent with the diagnosis, and enrolled 2-10 days after stroke onset.
3. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 8-15 at the time of screening.
4. Clinically stable at the time of enrollment.
5. Considered by the treating physician to be a suitable candidate for active rehabilitation.
6. 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.
Exclusion Criteria:
1. 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.
2. Contraindication to any study procedure.
3. Clinically unstable condition within 24 hours after thrombolysis (intravenous/endovascular) or thrombectomy.
4. Use of Cerebrolysin, piracetam, erythropoietin, edaravone, or vinpocetine within 30 days prior to enrollment.
5. Current use of finished medicinal products or herbal medicinal products containing ingredients that overlap with any component of MLC901.
6. Participation in another investigational drug or medical device trial within 30 days prior to enrollment.
7. 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).
8. History of food allergy or hypersensitivity to any component of MLC901
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