This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.
A total of 540 patients will be included with approximately 180 participants randomized to each treatment arm. Randomization will be performed centrally and stratified according to the following factors at the time of randomization: NIHSS (8 to 12, 13 to 18), age (\<65 years, ≥65 years) and received either intravenous or endovascular thrombolysis/thrombectomy (no, yes). Efficacy clinical assessments will include mRS, FMA, ARAT, 10MWT, NIHSS, Barthel Index, EQ-5D-5L, MoCA, PROMIS-10, and occurrence of recurrent vascular event. Each participant 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. The C-SSRS will be used to screen for suicidal ideation and behavior. Blood samples will be collected and stored for future studies on circulating compounds and pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
modified Rankin Scale
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: 24 weeks
Fugl-Meyer motor Assessment (FMA)
Time frame: 12, 24 weeks
Action Research Arm Test (ARAT)
Time frame: 12, 24 weeks
Timed 10-Meter Walk Test (10MWT)
Time frame: 12, 24 weeks
National Institute of Health Stroke Scale total and motor scores
The maximum possible score is 42 (severe), with the minimum score being a 0 (no symptoms)
Time frame: 12, 24 weeks
Barthel Index
Time frame: 4, 12, 24, 36 weeks
EuroQol 5 Dimensions 5 Levels
EQ5D-5L has 5 response levels: level 1 (no problems), 2 (slight), 3 (moderate), 4 (severe). Sometimes it is more convenient to dichotomies the levels into 'no problem's (level 1) and 'any problems' (level 2 to 5). In total, there are 3,125 possible unique health states defined by the EQ-5D-5L, with 11111 and 55555 representing the best and worst health states
Time frame: 4, 12, 24, 36 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 12, 24 weeks
Occurrence of recurrent vascular event
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24, 36 weeks
Patient Reported Outcome Measurement Information System - Global Health
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: 12, 24 weeks
Columbia-Suicide Severity Rating Scale screen
There are no specified clinical cutoffs for the C-SSRS due to the binary nature of the responses to items. When an item is endorsed, the clinician must pose follow-up inquiries to obtain additional information. The following can inform safety monitoring and treatment planning when patients endorse suicidal ideation, suicidal behavior, or both: * Suicidal ideation (Item endorsement: Yes; C-SSRS Categories 1-5) * Suicidal behavior (Item endorsement: Yes; C-SSRS Categories 6-10) * Suicidal ideation \& behavior (Item endorsement: Yes; C-SSRS Categories 1-10)
Time frame: 4, 12, 24, 36 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 36 weeks
modified Rankin Scale
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 36 weeks