Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT01795105
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABF Tourette's Disorder Post Marketing Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013981', 'term': 'Tic Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhw0159@otsuka.co.kr', 'title': 'Jeong, Hyo-Won', 'organization': 'KoreaOtsukaPharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole (Abilify® Tablets/Abilify® ODT)', 'otherNumAtRisk': 648, 'otherNumAffected': 49, 'seriousNumAtRisk': 648, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Appetite increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Emotional liability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mouth dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Weight increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency (n) of Subjects With Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Main Surveillance', 'description': 'Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.'}, {'id': 'OG001', 'title': 'Aripiprazole Long-term Surveillance', 'description': 'Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.'}], 'classes': [{'title': 'Number of patients reported for AE', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients reported for ADR', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up at least once from baseline to 6 weeks and at least 12weeks', 'description': 'Frequency (n) and Percentage(%) of subjects with Adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole Main Surveillance', 'description': 'Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer.'}, {'id': 'OG001', 'title': 'Aripiprazole Long-term Surveillance', 'description': 'Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.'}], 'classes': [{'title': 'at the first visit', 'categories': [{'measurements': [{'value': '4.31', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'at the last visit', 'categories': [{'measurements': [{'value': '2.73', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Mean change in the TS-CGI', 'categories': [{'measurements': [{'value': '-1.58', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at least 6, 12 weeks interval from baseline', 'description': 'Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment\n\n\\*TS-CGI scale 0=Not assessed\n\n1. Normal, not at all ill\n2. Borderline ill\n3. Mildly ill\n4. Moderately ill\n5. Markedly ill\n6. Severely ill\n7. Extremely ill', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole (Abilify® Tablets/Abilify® ODT)', 'description': "1. Pediatric patients 6 to 18 years of age with Tourette's Disorder\n2. Patients who are prescribed Abilify® Tablets/Abilify® ODT treatment as per investigator's medical judgment.\n3. Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, Abilify® ODT 10mg, 15mg)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '692'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '648'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole (Abilify® Tablets/Abilify® ODT)', 'description': 'Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=6 years and <12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '449', 'groupId': 'BG000'}]}]}, {'title': '>=12 years and <18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '533', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value."}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-02-28', 'size': 179607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-12-18T05:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2013-01-31', 'resultsFirstSubmitDate': '2018-01-14', 'studyFirstSubmitQcDate': '2013-02-17', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-04', 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency (n) of Subjects With Adverse Event', 'timeFrame': 'Follow-up at least once from baseline to 6 weeks and at least 12weeks', 'description': 'Frequency (n) and Percentage(%) of subjects with Adverse event'}], 'secondaryOutcomes': [{'measure': "Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)", 'timeFrame': 'at least 6, 12 weeks interval from baseline', 'description': 'Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment\n\n\\*TS-CGI scale 0=Not assessed\n\n1. Normal, not at all ill\n2. Borderline ill\n3. Mildly ill\n4. Moderately ill\n5. Markedly ill\n6. Severely ill\n7. Extremely ill'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Tourette's Disorder"]}, 'descriptionModule': {'briefSummary': 'This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).', 'detailedDescription': "This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients 6 to 18 years of age with Tourette's Disorder\n* Patients who are prescribed Abilify® treatment as per investigator's medical judgment.\n* Patients who gave written authorization to use their personal and health data\n* Patients starting Abilify® treatment after agreement is in place\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®\n* Patients who have been treated with Abilify®\n* Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption\n* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S\n* Patients participating in other clinical trial"}, 'identificationModule': {'nctId': 'NCT01795105', 'briefTitle': "ABF Tourette's Disorder Post Marketing Surveillance Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette\'s Disorder Under the "New Drug Re-Examination"', 'orgStudyIdInfo': {'id': '031-KOA-1101n'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aripiprazole (Abilify® Tablets/Abilify® ODT)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '561-712', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '131-795', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}