Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke
Phase 2
Terminated
- Conditions
- Fatigue
- Interventions
- Drug: BP1.3656
- Registration Number
- NCT05240560
- Lead Sponsor
- Bioprojet
- Brief Summary
Multicenter, randomized, double blind, parallel-group, placebo-controlled proof of concept study evaluating efficacy and safety of BP1.3656 in patients with fatigue following ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BP1.3656 BP1.3656 1 tablet of 30 microgram (µg), 60µg or 90µg of BP1.3656 per day Placebo BP1.3656 1 tablet of matching placebo per day
- Primary Outcome Measures
Name Time Method Multidimensional Fatigue Inventory (MFI-20) global score Week 8 20-item self-report instrument designed to measure fatigue experienced by the participant lately scored from 20 to 100. Higher scores show higher levels of fatigue.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Inselspital Berne
🇨🇭Berne, Switzerland
Hôpital Pellegrin - CHU BORDEAUX
🇫🇷Bordeaux, France