Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-27 @ 1:43 PM
Study NCT ID:
NCT00738595
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2008-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614721', 'term': 'sembragiline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The four-week continuous quit rate over the last four weeks of treatment', 'timeFrame': 'Last 4 weeks of therapy'}], 'secondaryOutcomes': [{'measure': '7 -week abstinence', 'timeFrame': '7 weeks post quit day'}, {'measure': '7-day point prevalence quit rate', 'timeFrame': 'weekly for 7 weeks'}, {'measure': 'Daily cigarettes smoked', 'timeFrame': 'Daily'}, {'measure': 'Change from baseline in the number of cigarettes smoked', 'timeFrame': 'Week 8'}, {'measure': 'Minnesota Nicotine Withdrawal Scale', 'timeFrame': 'Weekly'}, {'measure': 'Brief Questionnaire of Smoking Urges', 'timeFrame': 'Weekly'}, {'measure': 'Modified Cigarette Evaluation Questionnaire', 'timeFrame': 'Weekly'}, {'measure': 'Adverse Events', 'timeFrame': 'Weekly'}, {'measure': 'Laboratory investigations (Haematology & biochemistry)', 'timeFrame': 'Weekly'}, {'measure': 'ECGs', 'timeFrame': 'Weekly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37230961', 'type': 'DERIVED', 'citation': 'Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoker of at least 10 cigarettes daily\n* Motivated to quit smoking\n* Reports at least one unsuccessful attempt to quit in the last 2 years\n* In generally good health\n* Provides written informed consent to participate in the sudy\n\nExclusion Criteria:\n\n* Pregnant or nursing females.\n* Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter\n* History of anaphylaxis\n* History of alcohol or drug abuse\n* History of or current significant medical or psychiatric disorder\n* History or presence of cataract or abnormality identified by slit lamp investigation\n* Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.\n* Any medicine contraindicated for use with MAO inhibitors.\n* Have or be a carrier of hepatitis B or c or HIV 1 or 2\n* Use of tobacco products other than cigarettes\n* Use of nicotine replacement therapy in the past month\n* Received an investigational drug in the past 30 days\n* Previous participation in a study with a MAO-B inhibitor'}, 'identificationModule': {'nctId': 'NCT00738595', 'briefTitle': 'Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evotec International GmbH'}, 'officialTitle': 'Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.', 'orgStudyIdInfo': {'id': 'EVT 302/3009'}, 'secondaryIdInfos': [{'id': 'EUDRACT No.: 2008-002472-99'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'EVT 302, 5 mg once Daily', 'interventionNames': ['Drug: EVT 302']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'EVT 302 plus open label Nicotine replacement', 'interventionNames': ['Drug: EVT 302 plus open label Nicotine replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Placebo plus nicotine replacement therapy', 'interventionNames': ['Drug: Placebo plus open label Nicotine Replacement']}], 'interventions': [{'name': 'EVT 302', 'type': 'DRUG', 'description': 'EVT 302 5 mg once daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match EVT 302, 5 mg', 'armGroupLabels': ['2']}, {'name': 'EVT 302 plus open label Nicotine replacement', 'type': 'DRUG', 'description': 'Double-blind EVT 302 plus open label nicotine replacement', 'armGroupLabels': ['3']}, {'name': 'Placebo plus open label Nicotine Replacement', 'type': 'DRUG', 'description': 'Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Evotec Study Site 2', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Evotec Study Site 3', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Evotec Study Site 8', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Evotec Study Site 4', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Evotec Study Site 5', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Görlitz', 'country': 'Germany', 'facility': 'Evotec Study Site 7', 'geoPoint': {'lat': 51.15518, 'lon': 14.98853}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Evotec Study Site 1', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Evotec Study Site 6', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'Evotec Study Site 9', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}], 'overallOfficials': [{'name': 'H D Stahl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ClinPharm International, Leipzig, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evotec Neurosciences GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PRA Health Sciences', 'class': 'INDUSTRY'}, {'name': 'Clinpharm International Management Holding GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr S P Jones, VP Clinical Development', 'oldOrganization': 'Evotec'}}}}