Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke

Inclusion Criteria: * Males or females 18 years old or more; * Diagnosis of ischemic stroke at least one month and not more than six months prior to screening; * Persistent fatigue since the stroke with a score ≥ 50 across all domains of the Multidimensional Fatigue Inventory (MFI-20); * Modified Rankin Score (mRS) \< 3; * Capability to participate in all study tests according to the investigator; * Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to any study specific procedure; * Females of child-bearing potential must have a negative pregnancy test performed at the screening and randomization visits and use a medically accepted effective method of birth control, agree to continue this method for the duration of the study up until three weeks after last treatment intake. Exclusion Criteria: * Any identified etiology for fatigue other than stroke (except post-stroke depression) according to the investigator; * History of psychosis; * Current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression, or organic brain syndrome preventing the patients from completing study assessments; * Patients at risk of suicide according to the investigator; * Major cognitive disorders, dementia according to the investigator; * History of epilepsy or seizures disorder; * History of alcohol or drugs (i.e. cannabis, cocaine, amphetamines or opioids) (ab)use/dependence within the 12 months prior to screening or with a positive drug test at screening; * Glomerular filtration rate \<60 mL/min/1.73m² according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; * Clinically significant cardiovascular abnormalities (including clinically relevant ECG abnormalities) or, clinically significant hematological, neurological, endocrine abnormalities, severe hepatic impairment or Liver Function Tests (ASAT, ALAT) \> 3 ULN, or abnormal clinical laboratory results (in most cases \> 3ULN); * Other active clinically significant illness, infection, acid-related gastric disorder, or neoplastic pathology within the last 3 years (patients with fully cured non-melanoma skin cancer or in-situ carcinoma of the cervix are eligible) which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise his/her study participation.