Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-03-22 @ 11:42 AM
Study NCT ID:
NCT00380003
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2006-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of EVT 201 to Treat Insomnia
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': 'C549312', 'term': 'EVT 201'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-29', 'studyFirstSubmitDate': '2006-09-22', 'studyFirstSubmitQcDate': '2006-09-22', 'lastUpdatePostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time'}, {'measure': 'Wake after sleep onset'}], 'secondaryOutcomes': [{'measure': 'Latency to persistent sleep'}, {'measure': 'Number of awakenings'}, {'measure': 'Total wake time'}, {'measure': 'Minutes of stages 1-4 and REM sleep'}, {'measure': 'REM latency'}, {'measure': 'Patient reported sleep variables'}, {'measure': 'Residual sedation measures'}, {'measure': 'Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.'}]}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have a diagnosis of primary insomnia\n* over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours\n* must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period\n* must be willing and able to complete a sleep diary and questionnaires\n\nExclusion Criteria:\n\n* must not have a clinically significant or unstable medical condition that may interfere with sleep\n* must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder\n* must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants\n* must not intentionally nap 3 (or more) times per week\n* must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)'}, 'identificationModule': {'nctId': 'NCT00380003', 'briefTitle': 'Efficacy Study of EVT 201 to Treat Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evotec International GmbH'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients', 'orgStudyIdInfo': {'id': '2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EVT 201', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'St Petersburg Sleep Disorders Center', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '63017', 'city': 'Chesterfield (St Louis)', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Tri-State Sleep Disorders Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'James K Walsh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evotec Neurosciences GmbH', 'class': 'INDUSTRY'}}}}