NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke

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.

Safety will be assessed throughout the study through the monitoring of adverse events and hemorrhagic complications.

Inclusion criteria

• 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.

Exclusion criteria

• 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 MLC901.
• 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