Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-03-30 @ 8:10 PM
Study NCT ID:
NCT00576732
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '609 730 2317', 'title': 'Clinical Leader', 'organization': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Double-blind period: 6 weeks. Open-label period: 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.', 'otherNumAtRisk': 35, 'otherNumAffected': 20, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 12, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.', 'otherNumAtRisk': 31, 'otherNumAffected': 27, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Open-label Risperidone', 'description': 'Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).', 'otherNumAtRisk': 79, 'otherNumAffected': 39, 'seriousNumAtRisk': 79, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '8.12', 'groupId': 'OG001'}, {'value': '-12.4', 'spread': '6.52', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-12.19', 'ciUpperLimit': '-3.52', 'pValueComment': 'Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.18', 'estimateComment': 'Mean difference is change in Risperidone high dose arm minus change in placebo arm.', 'groupDescription': 'A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.\n\nA clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value', 'testedNonInferiority': False}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-7.36', 'ciUpperLimit': '1.27', 'pValueComment': 'Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.17', 'estimateComment': 'Mean difference is change in Risperidone low dose arm minus change in placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward \\[LOCF\\])."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had at Least 25% Improvement in ABC-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.', 'testedNonInferiority': False}, {'pValue': '0.817', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward \\[LOCF\\])."}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impression Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.33', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Mean difference is change in Risperidone high dose arm minus change in placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.', 'testedNonInferiority': False}, {'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Mean difference is change in Risperidone low dose arm minus change in placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1="not ill", 2="very mild", 3="mild", 4="moderate", 5="marked", 6="severe", 7="extremely severe").', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward \\[LOCF\\])."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.', 'testedNonInferiority': False}, {'pValue': '0.985', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is not adjusted for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Investigator impression of change over time from double-blind baseline on a 7-point scale (1="very much improved", 2="much improved", 3="minimally improved", 4="no change", 5="minimally worse", 6="much worse", 7="very much worse").', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward \\[LOCF\\])."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose (mg/dL) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '8.20', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.81', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '9.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward \\[LOCF\\])."}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance (IR) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'OG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'OG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '1.07'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.76', 'upperLimit': '0.55'}, {'value': '0.45', 'groupId': 'OG002', 'lowerLimit': '-0.18', 'upperLimit': '1.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized subjects with \\>=1 dose of study medication and fasting glucose and insulin at baseline and at \\>=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (\\<45 kg, \\>=45 kg) and baseline IR."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose (mg/dL) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/RIS', 'description': 'Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'OG001', 'title': 'Ris Low Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'OG002', 'title': 'Ris High Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '12.27', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '12.26', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '8.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period."}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance (IR) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/RIS', 'description': 'Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'OG001', 'title': 'Ris Low Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'OG002', 'title': 'Ris High Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'FG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'FG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'FG003', 'title': 'Placebo/RIS', 'description': 'Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'FG004', 'title': 'Ris Low Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}, {'id': 'FG005', 'title': 'Ris High Dose/RIS', 'description': 'Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg).'}], 'periods': [{'title': 'DOUBLE BLIND', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'OTHER', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'OPEN LABEL', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '26 of 27 double-blind placebo completers and 4 of 8 placebo non-completers entered open-label.', 'groupId': 'FG003', 'numSubjects': '30'}, {'comment': '24 of 25 double-blind RIS low dose completers and 0 RIS low dose non-completers entered open-label.', 'groupId': 'FG004', 'numSubjects': '24'}, {'comment': 'All 25 double-blind RIS high dose completers and 0 RIS high dose non-completers entered open-label.', 'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'OTHER', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Double-blind Period. Oral solution for 6 weeks.'}, {'id': 'BG001', 'title': 'Risperidone Low Dose', 'description': 'Double-blind Period. Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'BG002', 'title': 'Risperidone High Dose', 'description': 'Double-blind Period. Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) for 6 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '2.57', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '3.42', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '3.11', 'groupId': 'BG002'}, {'value': '9.3', 'spread': '3.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States of America', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Categorical', 'classes': [{'title': '<12 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': '>=12 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2007-12-17', 'resultsFirstSubmitDate': '2010-09-02', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-02', 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Had at Least 25% Improvement in ABC-I', 'timeFrame': '6 weeks', 'description': 'ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).'}, {'measure': 'Change in Clinical Global Impression Severity (CGI-S)', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1="not ill", 2="very mild", 3="mild", 4="moderate", 5="marked", 6="severe", 7="extremely severe").'}, {'measure': 'Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.', 'timeFrame': '6 weeks', 'description': 'Investigator impression of change over time from double-blind baseline on a 7-point scale (1="very much improved", 2="much improved", 3="minimally improved", 4="no change", 5="minimally worse", 6="much worse", 7="very much worse").'}, {'measure': 'Change in Fasting Glucose (mg/dL) at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks'}, {'measure': 'Change in Insulin Resistance (IR) at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.'}, {'measure': 'Change in Fasting Glucose (mg/dL) at 6 Months', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Change in Insulin Resistance (IR) at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritability', 'Risperidone', 'Antipsychotic agent', 'Autism', 'Adolescents', 'Children'], 'conditions': ['Autistic Disorder', 'Autism']}, 'referencesModule': {'references': [{'pmid': '37811711', 'type': 'DERIVED', 'citation': 'Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.'}, {'pmid': '24350813', 'type': 'DERIVED', 'citation': 'Kent JM, Hough D, Singh J, Karcher K, Pandina G. An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder. J Child Adolesc Psychopharmacol. 2013 Dec;23(10):676-86. doi: 10.1089/cap.2012.0058.'}, {'pmid': '23212807', 'type': 'DERIVED', 'citation': 'Kent JM, Kushner S, Ning X, Karcher K, Ness S, Aman M, Singh J, Hough D. Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study. J Autism Dev Disord. 2013 Aug;43(8):1773-83. doi: 10.1007/s10803-012-1723-5.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=78&filename=CR014740_CSR.pdf', 'label': 'A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who have autism, and to evaluate the safety and tolerability of the drug for additional 26 weeks after the initial 6-week study period.', 'detailedDescription': 'Autistic Disorder is a condition that develops early in childhood and persists throughout life. Seventy-five percent of children and adolescents with autistic disorder have irritability symptoms such as aggression towards others, deliberate self-injurious behavior, temper tantrums, and quickly changing moods. These symptoms affect their daily functioning such as school performance, interactions with family members and compliance to treatment. Risperidone is an atypical antipsychotic agent that has been recently approved for the treatment of irritability associated with Autistic Disorder in children and adolescents aged 5 to 16 years. The approved dose range is 0.5-3 mg per day. The aim of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) of a lower dose (0.125 mg or 0.175 mg risperidone per day depending on body weight). The study will include three treatment groups. A placebo group, a low dose risperidone group and a higher dose risperidone group (1.25 mg or 1.75mg per day depending on body weight). This phase of the study will be 6 weeks. During the study, neither investigators nor the patients will be told which treatment the patient received. This is called "double blind". The placebo treatment is not expected to be effective. The higher dose group is expected to be effective. At the end of the study, data from the lower dose group will be compared to the placebo group to see if it is effective. Another aim of this study is to evaluate the safety and tolerability of risperidone. At the end of the 6-week double-blind period, patients may enter a 6-month open-label period during which all patients will receive risperidone. During this phase of the study, the doses can be adjusted to a maximum of 1.25 mg or 1.75mg per day depending on body weight. Both investigator and the patient will know what dose the patient is taking. About 93 patients will be randomized. The study will be conducted by investigators from about 15 clinics. Assessments of effectiveness include the Aberrant Behavior Checklist (ABC) subscales including the irritability subscale (ABC-I), the Clinical Global Impression of Change (CGI C); the Clinical Global Impression of Severity (CGI-S); the response rate, and the Compulsions Subscale of the Children\'s Yale-Brown Obsessive Compulsive Scale (CY BOCS). Safety evaluations include monitoring of adverse events, physical examinations, clinical laboratory tests, nighttime sleep quality and daytime drowsiness, and extrapyramidal symptoms (EPS) as assessed using the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale (BARS) and the Simpson-Angus Scale (SAS). Venous blood samples will be collected for the determination of plasma concentrations of risperidone and 9-hydroxyrisperidone. The study hypotheses are that the higher dose level of risperidone is significantly superior to placebo as measured by change from baseline on the ABC-I Subscale score at end point (Week 6 or early withdrawal) and that the lower dose level of risperidone is significantly superior to placebo as measured by change from baseline on the ABC-I Subscale score at end point (Week 6 or early withdrawal). Double-blind phase: Risperidone oral solutions taken once daily. Depending on body weight patients take 1.25 mL or 1.75 mL of either a 0.1 mg/mL or a 1.0 mg/mL risperidone solution or matching placebo, for 6 weeks. Open-label phase: Medication can be taken once or twice a day. Starting from 0.125mg or 0.175mg per day, drug levels are titrated over 2 weeks to a maximum dose level of 1.25 mg risperidone/day or 1.75 mg /day depending on body weight, for 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DSM-IV diagnosis of Autistic Disorder (299.00)\n* ABC-I Subscale score of greater than or equal to 18\n* CGI-S of greater than or equal to 4\n* mental age \\>18 months, body weight of at least 20 kg, seizure-free for at least 6 consecutive months and if on anticonvulsants must be on a dosage that has been stable for at least 4 weeks\n* Medication free for 1 week before the start of the study for all psychotropic drugs, except 4 weeks for fluoxetine and at least 8 weeks for injectable medications\n* Female patients must be premenarchal or sexually abstinent or, if heterosexually active, must practice an effective method of birth control.\n\nExclusion Criteria:\n\n* History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's\n* Any history of hypersensitivity to risperidone, or its excipients in formulation, or other known drug allergy\n* Patients who received risperidone within 3 months before screening (except p.r.n. use)\n* Patients who did not demonstrate sufficient clinical response to an adequate trial of risperidone treatment in the past (an adequate trial is defined as a period of at least 4 weeks at an adequate dose)\n* Neurologic disorder (e.g., Neuroleptic Malignant Syndrome, seizure disorders that are unstable, seizure activity within the past 6 months)\n* History of alcohol or substance dependence within 3 months of screening\n* Female subject who is pregnant (positive beta-HCG) or breast feeding\n* Patients with existing moderate or severe EPS or history of tardive dyskinesia\n* Patients who have received an experimental drug or used an experimental medical device within 3 months before the planned start of treatment."}, 'identificationModule': {'nctId': 'NCT00576732', 'briefTitle': 'A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety', 'orgStudyIdInfo': {'id': 'CR014740'}, 'secondaryIdInfos': [{'id': 'RISAUT4002'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'Risperidone low dose Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) qd or bid for 6 weeks', 'interventionNames': ['Drug: Risperidone low dose']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'Risperidone high dose Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) qd or bid for 6 weeks', 'interventionNames': ['Drug: Risperidone high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': '003', 'description': 'Placebo Oral solution qd or bid for 6 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral solution qd or bid for 6 weeks', 'armGroupLabels': ['003']}, {'name': 'Risperidone high dose', 'type': 'DRUG', 'description': 'Risperidone oral solution 1.25 mg (if \\<45 kg) or 1.75 mg (if \\>=45 kg) qd or bid for 6 weeks', 'armGroupLabels': ['002']}, {'name': 'Risperidone low dose', 'type': 'DRUG', 'description': 'Risperidone oral solution 0.125 mg (if \\<45 kg) or 0.175 mg (if \\>=45 kg) qd or bid for 6 weeks', 'armGroupLabels': ['001']}]}, 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'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}], 'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. 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