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

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

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.

Study Overview

• Status: Terminated
• Conditions: Fatigue
• Intervention / Treatment: Drug: BP1.3656

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Hôpital Pellegrin - CHU Bordeaux
• Switzerland
  • Berne, Switzerland, 3010
    • Inselspital Berne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by AEs collection	Safety assessment of BP1.3656 based on adverse events (AEs) reporting during treatment period.	Week 8
Change in Systolic blood pressure (BP) measurement	Safety assessment of BP1.3656 based on the measurement of systolic blood pressure in units of millimeters of mercury (mmHg)	From baseline to Week 8
Change in Diastolic blood pressure (BP) measurement	Safety assessment of BP1.3656 based on the measurement of Diastolic blood pressure in units of millimeters of mercury (mmHg)	From baseline to Week 8
Change in pulse	Safety assessment of BP1.3656 based on the measurement of pulse in beats/minute	From baseline to Week 8

Collaborators and Investigators

• Sponsor: Bioprojet
• Investigators: Principal Investigator: Claudio Bassetti, MD, Prof., Inselspital Bern, Department of Neurology, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Post-stroke fatigue
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Fatigue; Ischemic Stroke
• Other Study ID Numbers: P20-04 / BP1.3656; 2020-006006-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No