Status:
TERMINATED
Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke
Lead Sponsor:
Bioprojet
Conditions:
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05240560
Start Date
January 20 2023
End Date
February 8 2024
Last Update
August 9 2024
Active Locations (2)
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1
Hôpital Pellegrin - CHU BORDEAUX
Bordeaux, France, 33076
2
Inselspital Berne
Bern, Switzerland, 3010