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.
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.