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

NCT05240560 | Terminated Phase 2 DMC

• 2 other identifiers: P20-04 / BP1.36562020-006006-23
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

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.

Conditions

Fatigue

Keywords

Post-stroke fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by AEs collection

  Week 8

• Change in Systolic blood pressure (BP) measurement

  From baseline to Week 8

• Change in Diastolic blood pressure (BP) measurement

  From baseline to Week 8

Study Arms (2)

BP1.3656

EXPERIMENTAL

1 tablet of 30 microgram (µg), 60µg or 90µg of BP1.3656 per day

Drug: BP1.3656

Placebo

PLACEBO COMPARATOR

1 tablet of matching placebo per day

Drug: BP1.3656

Interventions

BP1.3656 DRUG

Histamine H3 receptor antagonist/inverse agonist

BP1.3656; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (2)

Hôpital Pellegrin - CHU BORDEAUX

Bordeaux, 33076, France

Location

Inselspital Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudio Bassetti, MD, Prof.

  Inselspital Bern, Department of Neurology, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo tablets will be identical in appearance to the BP1.3656 tablets.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 15, 2022
• Study Start: January 20, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (1)