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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
303
Metro Davao Medical And Research Center
Davao City, Davao Region, Philippines
Quirino Memorial Medical Center
Manila, Manila, Philippines
University of Santo Tomas Hospital
Manila, Manila, Philippines
Fugl-Meyer motor Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Time frame: 24 weeks
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each dose cohort
Time frame: up to 24 weeks
Fugl-Meyer motor Assessment (FMA)
Time frame: 12 and 24 weeks
modified Rankin Scale (mRS)
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who expire.
Time frame: 4, 12 and 24 weeks
Patient Reported Outcome Measurement Information System - Global Health (PROMIS-10)
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: 4, 12 and 24 weeks
National Institute of Health Stroke Scale (NIHSS)
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
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Baguio General Hospital and Medical Center
Baguio City, Philippines
West Visayas State University Medical Center
Iloilo City, Philippines
Jose R. Reyes Memorial Medical Center
Manila, Philippines
Manila Doctors Hospita
Manila, Philippines
Changi General Hospital
Singapore, Singapore, Singapore
National Neuroscience Institute (NNI) @ Tan Tock Seng Hospital (TTSH)
Singapore, Singapore, Singapore
Raffles Hospital
Singapore, Singapore
...and 1 more locations
Time frame: 12 and 24 weeks