Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 8:45 AM
Study NCT ID:
NCT00805350
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'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': 'C076033', 'term': 'SR 46349B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 637}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-02-05', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2008-12-04', 'dispFirstSubmitQcDate': '2016-02-05', 'studyFirstSubmitQcDate': '2008-12-08', 'dispFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of mean PSG-WASO on N41/N42', 'timeFrame': '6 weeks'}, {'measure': 'Change from baseline of mean PSG-NAW on N41/N42', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS', 'timeFrame': '6 weeks'}, {'measure': 'Patient-reported sleep parameters', 'timeFrame': '6 weeks'}, {'measure': 'Patient Global impression (PGI)', 'timeFrame': '6 weeks'}, {'measure': 'sleep architecture: percentage of time spent in each sleep stage (1, 2, 3-4/SWS, REM), shift to stage 1, shift to wake, stage 1 + WASO, [stages 3&4]/[stage 1 + WASO]).', 'timeFrame': '6 weeks'}, {'measure': 'Sleep Impact Scale (SIS)', 'timeFrame': '6 weeks'}, {'measure': 'SF-36 Health Survey', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Insomnia', 'Sleep Maintenance', 'Polysomnography'], 'conditions': ['Primary Insomnia']}, 'descriptionModule': {'briefSummary': "Primary objective:\n\n\\- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).\n\nSecondary objectives:\n\n* To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).\n* To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo.\n* To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.\n* To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire.\n* To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.\n* To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo.\n* To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey.\n* To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.", 'detailedDescription': 'Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks\n\nDuration of observation: 9 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria\n\nExclusion Criteria:\n\n* Inpatients.\n* Mean screening PSG-WASO for screening night 1+ screening night 2 \\< 45 mn, or screening night with PSG-WASO \\< 30 mn.\n* Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.\n* Mean screening PSG-LPS for screening night 1+ screening night 2 \\> 30 mn.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00805350', 'acronym': 'ECLIPSE', 'briefTitle': 'Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.', 'orgStudyIdInfo': {'id': 'EFC10844'}, 'secondaryIdInfos': [{'id': '2008-003791-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplivanserin', 'description': 'Eplivanserin 5 mg/day', 'interventionNames': ['Drug: Eplivanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of Eplivanserin 5 mg/day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eplivanserin', 'type': 'DRUG', 'otherNames': ['SR46349'], 'description': 'one 5 mg tablet once a day', 'armGroupLabels': ['Eplivanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of Eplivanserin one tablet once a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}