Clinical trial NCT05240560: Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke
Official title: A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fatigue
Keywords: Post-stroke fatigue
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI-20) global score
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by AEs collection
timeFrame: Week 8
measure: Change in Systolic blood pressure (BP) measurement
timeFrame: From baseline to Week 8
measure: Change in Diastolic blood pressure (BP) measurement
timeFrame: From baseline to Week 8
measure: Change in pulse
timeFrame: From baseline to Week 8
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin - CHU BORDEAUX
city: Berne
country: Switzerland
facility: Inselspital Berne
Study officials:
affiliation: Inselspital Bern, Department of Neurology, Bern, Switzerland
name: Claudio Bassetti, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: