Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 1:23 PM
Study NCT ID:
NCT01067235
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D002385', 'term': 'Cataplexy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516975', 'term': 'pitolisant'}, {'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cataplexy attacks reported on sleep diary', 'timeFrame': 'every days from screening visit (day-14) to final visit (day 56)'}], 'secondaryOutcomes': [{'measure': 'Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,', 'timeFrame': 'every days from screening visit (day-14) to final visit (day 56)'}, {'measure': 'Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).', 'timeFrame': 'at inclusion and after 8-week treatment'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'at each visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Narcolespy', 'Cataplexy', 'Excesssive daytime Sleepiness', 'Sleep Disorders', 'Sleep attacks', 'Orphan Drug', 'Pitolisant'], 'conditions': ['Narcolepsy', 'Cataplexy', 'Excessive Daytime Sleepiness']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy', 'detailedDescription': 'BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.\n\nThe objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy\n* patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months\n* partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS \\>or= 14 at the end of the baseline period\n\nExclusion Criteria:\n\n* Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances\n* Current or recent history of a substance abuse or dependence disorder including alcohol abuse\n* Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator\'s opinion would preclude the patient\'s participation'}, 'identificationModule': {'nctId': 'NCT01067235', 'acronym': 'Harmony2', 'briefTitle': 'Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy', 'organization': {'class': 'OTHER', 'fullName': 'Bioprojet'}, 'officialTitle': 'Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy', 'orgStudyIdInfo': {'id': 'P07-07 / BF2.649'}, 'secondaryIdInfos': [{'id': '2008-007845-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BF2.649 + Modafinil placebo', 'interventionNames': ['Drug: BF2.649']}, {'type': 'EXPERIMENTAL', 'label': 'BF2.649 + Modafinil', 'interventionNames': ['Drug: BF2.649 add on Modafinil']}], 'interventions': [{'name': 'BF2.649', 'type': 'DRUG', 'otherNames': ['Pitolisant'], 'description': 'BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks', 'armGroupLabels': ['BF2.649 + Modafinil placebo']}, {'name': 'BF2.649 add on Modafinil', 'type': 'DRUG', 'otherNames': ['Pitolisant', 'Modiodal'], 'description': 'BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks', 'armGroupLabels': ['BF2.649 + Modafinil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6903', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Neurocenter (EOC) of Southern Switzerland', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Claudio Bassetti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurocenter of Southern Switzerland,Lugano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioprojet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}