Fatigue
Conditions
Keywords
Post-stroke fatigue
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.
Interventions
DRUGBP1.3656
Histamine H3 receptor antagonist/inverse agonist
Sponsors
Bioprojet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The placebo tablets will be identical in appearance to the BP1.3656 tablets.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MFI-20) global score | Week 8 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by AEs collection | Week 8 | Safety assessment of BP1.3656 based on adverse events (AEs) reporting during treatment period. |
| Change in Systolic blood pressure (BP) measurement | From baseline to Week 8 | Safety assessment of BP1.3656 based on the measurement of systolic blood pressure in units of millimeters of mercury (mmHg) |
| Change in Diastolic blood pressure (BP) measurement | From baseline to Week 8 | Safety assessment of BP1.3656 based on the measurement of Diastolic blood pressure in units of millimeters of mercury (mmHg) |
| Change in pulse | From baseline to Week 8 | Safety assessment of BP1.3656 based on the measurement of pulse in beats/minute |
Countries
France, Switzerland
Outcome results
None listed