Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-21 @ 9:20 PM
Study NCT ID:
NCT00464061
Status:
TERMINATED
Last Update Posted:
2016-05-26
First Post:
2007-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], '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': 'C079049', 'term': 'volinanserin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1847}}, 'statusModule': {'whyStopped': "Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-26', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2007-04-19', 'dispFirstSubmitQcDate': '2016-04-26', 'studyFirstSubmitQcDate': '2007-04-19', 'dispFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)', 'timeFrame': 'at 3 months'}, {'measure': 'Efficacy (sub-study): change from baseline for glycemic measure HbA1c', 'timeFrame': 'at 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Efficacy: change from baseline of the pr-WASO', 'timeFrame': 'at 6 and 12 months'}, {'measure': 'Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire', 'timeFrame': 'at 3 months'}, {'measure': 'Safety: adverse events and laboratory abnormalities', 'timeFrame': 'during 12 months of treatment'}]}, 'conditionsModule': {'keywords': ['Sleep problems', 'Insomnia', 'Sleeplessness', 'Primary insomnia', 'Insomnia disorder'], 'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria\n* Disturbances of sleep maintenance criteria based on participant's information related to sleep pattern during the preceding month\n\nSub-study :\n\n* Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)\n\nExclusion Criteria:\n\n* Females who are lactating or who are pregnant\n* Night shift workers, and individuals who nap 3 or more times per week over the preceding month\n* Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day\n* Participation in another trial having received study medication within 1 month before the screening visit\n* Body Mass Index ≥ 33\n* Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication\n* Use of any substance with psychotropic effects or properties know to affect sleep/wake\n* History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia\n* Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder\n* Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00464061', 'acronym': 'SAMS', 'briefTitle': 'Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'LTE6673'}, 'secondaryIdInfos': [{'id': 'EudraCT : 2006-004942-18'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volinanserin', 'interventionNames': ['Drug: Volinanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Volinanserin', 'type': 'DRUG', 'otherNames': ['M100907'], 'description': 'oral administration', 'armGroupLabels': ['Volinanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral administration', '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': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Macquarie Park', 'country': 'Australia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Causeway Bay', 'country': 'Hong Kong', 'facility': 'Anofi-Aventis Administrative Office', 'geoPoint': {'lat': 22.28189, 'lon': 114.18515}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}