NeuroAiD test in mild to moderate ischemic stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label trial will compare MLC901 plus standard treatment versus standard treatment alone in 80 adults aged 18–80 with mild to moderate ischemic stroke, enrolled 2–10 days after onset. Participants will receive 400 mg of MLC901 three times daily for 12 weeks, with a possible follow-up at week 24 to assess durability. Outcomes include quality of life, satisfaction with treatment, functional ability, NIHSS, mRS, muscle strength, and MRI infarct volume, along with safety monitoring for adverse events and hemorrhagic complications. The study aims to determine if the NeuroAiD formulation provides additional benefit over standard care during rehabilitation.

Why it matters

Who can join: the full rules

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

Where it's running

• Traditional Medicine Institute
  Ho Chi Minh City, Vietnam Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Deep phenotyping to explore recovery in young adults after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.