Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-22 @ 10:15 PM
Study NCT ID:
NCT01568216
Status:
TERMINATED
Last Update Posted:
2015-07-30
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625754', 'term': '(R)-2-(4-(phenyl(3-(trifluoromethyl)phenyl)methyl)piperazin-1-yl)acetic acid'}]}}, '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': 121}}, 'statusModule': {'whyStopped': 'Toxic Epidermal Necrolysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2014-05-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2012-02-27', 'dispFirstSubmitQcDate': '2014-05-08', 'studyFirstSubmitQcDate': '2012-03-29', 'dispFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score', 'timeFrame': '12 Weeks', 'description': 'NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint'}], 'secondaryOutcomes': [{'measure': 'Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12', 'timeFrame': '12 weeks', 'description': 'NSA-16 = 16-item Negative Symptom Assessment Scale'}, {'measure': 'Change from baseline to week 12 on the PANSS total score and Marder factor scores', 'timeFrame': '12 weeks', 'description': 'Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'Change from baseline to week 12 on the CGI-S', 'timeFrame': 'Week 12', 'description': 'Clinical Global Impression Severity Scale (CGI-S)'}, {'measure': 'CGI-I scores at week 12', 'timeFrame': '12 weeks', 'description': 'Clinical Global Impression Improvement (CGI-I)'}, {'measure': 'Change on cognition battery', 'timeFrame': '12 weeks'}, {'measure': 'Change in personal and social functioning', 'timeFrame': '12 weeks'}, {'measure': 'Change on patient reported outcomes', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia negative symptoms'], 'conditions': ['Schizophrenia']}, '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.'}, {'pmid': '27789188', 'type': 'DERIVED', 'citation': 'Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia\n* Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥20\n* Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30\n* Receiving stable antipsychotic therapy for at least 8 weeks prior to screening\n* Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening\n* Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study\n* The subject or subject's legally acceptable representative has provided informed consent.\n\nExclusion Criteria:\n\n* Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70\n* Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam\n* Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening\n* Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening\n* Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study\n* Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).\n* Other criteria may apply"}, 'identificationModule': {'nctId': 'NCT01568216', 'briefTitle': '20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"', 'orgStudyIdInfo': {'id': '20101299'}, 'secondaryIdInfos': [{'id': '2011-004844-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 747 - Dose 1', 'interventionNames': ['Drug: AMG 747']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 747 - Dose 2', 'interventionNames': ['Drug: AMG 747']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 747 - Dose 3', 'interventionNames': ['Drug: AMG 747']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMG 747', 'type': 'DRUG', 'description': 'Three dose levels once-daily oral administration', 'armGroupLabels': ['AMG 747 - Dose 1', 'AMG 747 - Dose 2', 'AMG 747 - Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once-daily oral administration', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '92408', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '11004', 'city': 'Glen Oaks', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.74705, 'lon': -73.71152}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27603', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '5065', 'city': 'Glenside', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.94275, 'lon': 138.63375}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6010', 'city': 'Mount Claremont', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.96177, 'lon': 115.78337}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V2A 4M4', 'city': 'Penticton', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.48062, 'lon': -119.58584}}, {'zip': 'K7L 4X3', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '1309', 'city': 'Takapuna, Auckland', 'country': 'New Zealand', 'facility': 'Research Site'}, {'zip': '141371', 'city': "Khot'kovo", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.76349, 'lon': 35.22634}}, {'zip': '107076', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '192019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '539747', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Research Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08940', 'city': 'Cornellà de Llobregat', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.35, 'lon': 2.08333}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}