Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of OSU6162 in the treatment of residual symptoms after stroke

INTERVENTION: Product Name: OSU6162 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Stroke Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of OSU6162 with respect to treatment response in post stroke patients Primary end point(s): The primary endpoints will be change from baseline in total score on Clinical Global Impression of Change (CGI‐C) after 16 weeks of treatment with OSU6162or placebo, with data Collection at baseline, week 4, 8, 12 and 16. Secondary Objective: Not applicable SECONDARY OUTCOME: Secondary end point(s): Mental Fatigue Scale (MFS) ; Fatigue Severity Scale (FSS) ; Becks Depression Inventory (BDI) ; Frenchay Activity Index (FAI) ; SF‐36 ; Stroke Impact Scale (SIS) ; after 4, 8, 12 and 16 weeks treatment. ; ‐ Plasmakoncentration of OSU6162 after 4 and 16 weeks treatment ; ‐ Vital signs and blood and urine samples at screening/baseline and after 4, 8, 12 and 16 weeks of treatment ; ‐ Physical and neurological examinations ; ‐ Adverse Event INCLUSION CRITERIA: 1. Signed written informed consent 2. Between 18‐80 years 3. Stroke >12 months prior to the start of the study. Patients must have had the location of their stroke evaluated through a CT scan, noted in their hospital notes 4. Anamnestic evidence of post stroke residual symptoms at least 3 months prior to the start of the study 5. At least 10.5 points on Mental Fatigue scale at the screening visit (week ‐2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10