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

Study Overview
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Brief Summary
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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.

Official Title
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A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke

Conditions
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Fatigue

Intervention / Treatment
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* Drug: BP1.3656


Participation Criteria
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Eligibility Criteria
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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 ≥ 60 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP1.3656<br>1 tablet of 30 microgram (µg), 60µg or 90µg of BP1.3656 per day | Drug: BP1.3656<br>* Histamine H3 receptor antagonist/inverse agonist<br>|
| Placebo Comparator: Placebo<br>1 tablet of matching placebo per day | Drug: BP1.3656<br>* Histamine H3 receptor antagonist/inverse agonist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory (MFI-20) global score | 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. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-stroke fatigue