Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT05240560
Status:
TERMINATED
Last Update Posted:
2024-08-09
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The placebo tablets will be identical in appearance to the BP1.3656 tablets.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by AEs collection', 'timeFrame': 'Week 8', 'description': 'Safety assessment of BP1.3656 based on adverse events (AEs) reporting during treatment period.'}, {'measure': 'Change in Systolic blood pressure (BP) measurement', 'timeFrame': 'From baseline to Week 8', 'description': 'Safety assessment of BP1.3656 based on the measurement of systolic blood pressure in units of millimeters of mercury (mmHg)'}, {'measure': 'Change in Diastolic blood pressure (BP) measurement', 'timeFrame': 'From baseline to Week 8', 'description': 'Safety assessment of BP1.3656 based on the measurement of Diastolic blood pressure in units of millimeters of mercury (mmHg)'}, {'measure': 'Change in pulse', 'timeFrame': 'From baseline to Week 8', 'description': 'Safety assessment of BP1.3656 based on the measurement of pulse in beats/minute'}], 'primaryOutcomes': [{'measure': 'Multidimensional Fatigue Inventory (MFI-20) global score', 'timeFrame': 'Week 8', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-stroke fatigue'], 'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 years old or more;\n* Diagnosis of ischemic stroke at least one month and not more than six months prior to screening;\n* Persistent fatigue since the stroke with a score ≥ 50 across all domains of the Multidimensional Fatigue Inventory (MFI-20);\n* Modified Rankin Score (mRS) \\< 3;\n* Capability to participate in all study tests according to the investigator;\n* Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to any study specific procedure;\n* 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.\n\nExclusion Criteria:\n\n* Any identified etiology for fatigue other than stroke (except post-stroke depression) according to the investigator;\n* History of psychosis;\n* Current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression, or organic brain syndrome preventing the patients from completing study assessments;\n* Patients at risk of suicide according to the investigator;\n* Major cognitive disorders, dementia according to the investigator;\n* History of epilepsy or seizures disorder;\n* 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;\n* Glomerular filtration rate \\<60 mL/min/1.73m² according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula;\n* 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);\n* 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.'}, 'identificationModule': {'nctId': 'NCT05240560', 'briefTitle': 'Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Bioprojet'}, 'officialTitle': 'A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke', 'orgStudyIdInfo': {'id': 'P20-04 / BP1.3656'}, 'secondaryIdInfos': [{'id': '2020-006006-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BP1.3656', 'description': '1 tablet of 30 microgram (µg), 60µg or 90µg of BP1.3656 per day', 'interventionNames': ['Drug: BP1.3656']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 tablet of matching placebo per day', 'interventionNames': ['Drug: BP1.3656']}], 'interventions': [{'name': 'BP1.3656', 'type': 'DRUG', 'description': 'Histamine H3 receptor antagonist/inverse agonist', 'armGroupLabels': ['BP1.3656', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin - CHU BORDEAUX', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Berne', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Claudio Bassetti, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital Bern, Department of Neurology, Bern, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioprojet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}