Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-26 @ 5:45 PM
Study NCT ID:
NCT01072968
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516975', 'term': 'pitolisant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ESS (Epworth Sleepiness Scale) change from baseline', 'timeFrame': 'From baseline to week 12 and week 51'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multicenter', 'Randomized', 'Double-blind', 'Efficacy and safety study', 'BF2.649 versus placebo', 'Patients suffering from Obstructive Sleep Apnea', 'Complaining from Excessive Daytime Sleepiness', 'Refusing nasal Continuous Positive Airway Pressure'], 'conditions': ['Obstructive Sleep Apnea', 'Excessive Daytime Sleepiness']}, 'referencesModule': {'references': [{'pmid': '37979718', 'type': 'DERIVED', 'citation': 'Pepin JL, Attali V, Causse C, Verbraecken J, Hedner J, Lecomte I, Tamisier R, Levy P, Lehert P, Dauvilliers Y. Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA. Chest. 2024 Mar;165(3):692-703. doi: 10.1016/j.chest.2023.11.017. Epub 2023 Nov 17.'}, {'pmid': '31917607', 'type': 'DERIVED', 'citation': 'Dauvilliers Y, Verbraecken J, Partinen M, Hedner J, Saaresranta T, Georgiev O, Tiholov R, Lecomte I, Tamisier R, Levy P, Scart-Gres C, Lecomte JM, Schwartz JC, Pepin JL; HAROSA II Study Group collaborators. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1135-1145. doi: 10.1164/rccm.201907-1284OC.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.\n\nThis double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.', 'detailedDescription': 'The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.\n\nThe aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with OSA still complaining EDS,refusing nCPAP\n* ESS score ≥ 12\n\nExclusion Criteria:\n\n* Patients suffering from insomnia without OSA\n* Co-existing narcolepsy\n* Patient with sleep debt not due to OSA\n* Acute or chronic severe disease'}, 'identificationModule': {'nctId': 'NCT01072968', 'acronym': 'HAROSA2', 'briefTitle': 'BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.', 'organization': {'class': 'OTHER', 'fullName': 'Bioprojet'}, 'officialTitle': 'Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy', 'orgStudyIdInfo': {'id': 'P09-09 / BF2.649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BF2.649', 'description': 'BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg', 'interventionNames': ['Drug: BF2.649']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules of placebo containing lactose with low, medium and high dosage', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BF2.649', 'type': 'DRUG', 'otherNames': ['Pitolisant'], 'description': '1 capsule per day in the morning before the breakfast', 'armGroupLabels': ['BF2.649']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 capsule per day in the morning before the breakfast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Evelyne De Paillette, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bioprojet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioprojet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}