Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00968851
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573817', 'term': '7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide'}]}}, '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': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'dispFirstSubmitDate': '2012-02-23', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2009-08-28', 'dispFirstSubmitQcDate': '2012-03-02', 'studyFirstSubmitQcDate': '2009-08-28', 'dispFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.', 'timeFrame': '84 days'}], 'secondaryOutcomes': [{'measure': 'Assessment of Clinical Efficacy', 'timeFrame': '84 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Central nervous System Diseases', 'Cognition'], 'conditions': ['Schizophrenia', 'Central Nervous System Diseases', 'Cognition']}, 'referencesModule': {'references': [{'pmid': '28433500', 'type': 'DERIVED', 'citation': 'Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.\n\nPatients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)\n* Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks\n* Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4\n* A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6\n* A minimal level of depression; Calgary Depression Scale total score ≤10\n* Must have a general health status acceptable for participation in a 12-week clinical trial\n* Fluency (oral and written) in the language in which the standardized tests will be administered\n* If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing\n\nExclusion Criteria:\n\nGeneral\n\n* Insufficiently controlled diabetes mellitus in the judgment of the investigator\n* Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ\n* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study\n* Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction'}, 'identificationModule': {'nctId': 'NCT00968851', 'briefTitle': 'Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'FORUM Pharmaceuticals Inc'}, 'officialTitle': 'A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy', 'orgStudyIdInfo': {'id': 'EVP-6124-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EVP-6124 0.3 mg', 'description': 'one 0.3 mg capsule every day for 84 days', 'interventionNames': ['Drug: EVP-6124']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EVP-6124 1.0 mg', 'description': 'one 1.0 mg capsule every day for 84 days.', 'interventionNames': ['Drug: EVP-6124']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo every day for 84 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EVP-6124', 'type': 'DRUG', 'description': 'Arms: 1', 'armGroupLabels': ['EVP-6124 0.3 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Arm: 3', 'armGroupLabels': ['Placebo']}, {'name': 'EVP-6124', 'type': 'DRUG', 'description': 'Arms: 2', 'armGroupLabels': ['EVP-6124 1.0 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Intergrated Medical and Behavioral Associates', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Affiliated Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Schuster Medical Research Institute', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Scientific Clinical Research, Inc.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Uptown Research Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Behavioral Health', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'CBH Health, LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '20850', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CRI Worldwide', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Trials, Inc.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37212-8645', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Psychiatric Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Clinical Trials, L.P.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'InSite Clinical Research', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '163530', 'city': 'Arkhangelsk', 'country': 'Russia', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '107076', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '190121', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '355108', 'city': 'Stavropol', 'country': 'Russia', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Site 2', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Site 3', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '18000', 'city': 'Niš', 'country': 'Serbia', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'zip': '95006', 'city': 'Crimea', 'country': 'Ukraine'}, {'zip': '49005', 'city': 'Dnipro', 'country': 'Ukraine', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '02660', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04080', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '65014', 'city': 'Odesa', 'country': 'Ukraine', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '21005', 'city': 'Vinnytsia', 'country': 'Ukraine', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Chris Southard', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Syneos Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FORUM Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}