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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240560
• Other study ID #: P20-04 / BP1.3656
• Secondary ID: 2020-006006-23
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Bioprojet
• Contact: Stéphanie Renaux
• Phone: +33147036633
• Email: s.renaux[@]bioprojet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Ischemic Stroke

Intervention

Drug:
• BP1.3656
Histamine H3 receptor antagonist/inverse agonist

Locations

Country	Name	City	State
France	Hôpital Pellegrin - CHU BORDEAUX	Bordeaux
Switzerland	Inselspital Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Change in pulse	Safety assessment of BP1.3656 based on the measurement of pulse in beats/minute	From baseline to Week 8
Primary	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