Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02618434
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gceresoliborroni@supernus.com', 'phone': '3018382521', 'title': 'Gianpiera Ceresoli-Borroni Director Clinical Research', 'organization': 'Supernus Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks', 'description': 'Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 13, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Low Dose SPN-810 (18 mg)', 'description': 'Subjects were randomized to receive SPN-810 9 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 10, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 23, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blood prolactin increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Post-Traumatic Stress Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.12', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '63.4'}, {'value': '-51.64', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '105.3'}]}]}], 'analyses': [{'pValue': '0.9383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-8.96', 'ciUpperLimit': '7.84', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks', 'description': 'The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.', 'unitOfMeasure': 'Percent Change of IA behaviors', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.518', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.776', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.773', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '1.068', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.997', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.089', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.090', 'groupDescription': 'This analysis pertains to Visit 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'This analysis pertains to Visit 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'This analysis pertains to Visit 6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks.', 'description': "The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change between Baseline (Visit 3/Day 1) and three time points: Visit 4 (Week 1); Visit 5 (Week 2) and Visit 6 (Week 5).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population included subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry.\n\nBased on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.113', 'groupDescription': 'This analysis pertains to Visit 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'groupDescription': 'This analysis pertains to Visit 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'This analysis pertains to Visit 6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks', 'description': "The Clinical Global Impression - Improvement Scale (CGI-I) is an assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of treatment.\n\nCGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'SPN-810 (36 mg): Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Physical Functioning Summary Score At Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.98', 'spread': '11.461', 'groupId': 'OG000'}, {'value': '10.86', 'spread': '12.120', 'groupId': 'OG001'}]}]}, {'title': 'Psychosocial Health Summary Score At Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '6.150', 'groupId': 'OG000'}, {'value': '-2.29', 'spread': '9.282', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '4.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.613', 'groupDescription': 'This analysis pertains to the Physical Functioning Summary Score at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.21', 'ciLowerLimit': '-4.08', 'ciUpperLimit': '-0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.952', 'groupDescription': 'This analysis pertains to the Psychosocial Health Summary Score at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The CHQ-PF28 is a short generic measure of health status and health-related quality of life. The 28 items have 4, 5, or 6 response options, divided over 8 multi-item scales (physical functioning, general behavior, mental health, self-esteem, general health perceptions, parental impact: emotional, parental impact: time, and family activities) and 5 single item concepts (role functioning: emotional/behavior, role functioning: physical, bodily pain, family cohesion, and change in health). In addition, the individual scale scores will be aggregated to derive 2 summary component scores: the physical functioning and psychosocial health summary scores. The range on subscales and the overall scale is 0-100 (0 = worst possible health state; 100 = best possible health state).\n\nData represent the change from Baseline (Visit 3) to one time point, Visit 6 (Week 5).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'SPN-810 (36 mg): Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Total Score at Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.29', 'spread': '12.830', 'groupId': 'OG000'}, {'value': '-7.38', 'spread': '15.757', 'groupId': 'OG001'}]}]}, {'title': 'Parental Distress Domain at Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '5.486', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '6.313', 'groupId': 'OG001'}]}]}, {'title': 'Parent-Child Dysfunctional Interaction Domain at Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'spread': '5.593', 'groupId': 'OG000'}, {'value': '-2.42', 'spread': '6.663', 'groupId': 'OG001'}]}]}, {'title': 'Difficult Child Domain at Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.14', 'spread': '5.898', 'groupId': 'OG000'}, {'value': '-3.94', 'spread': '6.406', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-5.00', 'ciUpperLimit': '2.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.000', 'groupDescription': 'This analysis pertains to the Total Score at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '1.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.807', 'groupDescription': 'This analysis pertains to the Parental Distress Domain score at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '1.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.801', 'groupDescription': 'This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1426', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.849', 'groupDescription': 'This analysis pertains to the Difficult Child Domain score Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The PSI-4-SF is a 36-item self-report measure of parenting stress. Three subscales Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC) consist of 12 items each. Parent chooses one of the 5 responses against each item. The 5 responses are: Strongly Agree (SA), Agree (A), Not Sure (NS), Disagree (D), and Strongly Disagree (SD) to indicate the degree to which they agree with each statement. The PD subscale raw score ranges from 12-60, P-CDI and DC each subscale raw score ranges from 16-56. The total stress raw score is the sum of the three subscales (PD+P-CDI+ DC) with a minimum score of 44 and a maximum score of 172. The total stress score is then converted into the percentile score. Parents with a 91st percentile or higher are experiencing clinically significant levels of stress. Data represents the mean change in percentile score from Baseline (Visit 3) and one time point, Visit 6 (Week 5).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Visit 4', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'groupDescription': 'This analysis pertains to Visit 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.143', 'groupDescription': 'This analysis pertains to Visit 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'This analysis pertains to Visit 6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks', 'description': "The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subjects' global functioning prior to and after administration of a study medication. The scale was also rated by the Caregiver to assess the improvement of IA behaviors.\n\n. CGI-I was evaluated by the Caregiver at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': 'Inattention subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.539', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.593', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity/Impulsivity subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.590', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.681', 'groupId': 'OG001'}]}]}, {'title': 'Oppositional Defiant Disorder subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.732', 'groupId': 'OG001'}]}]}, {'title': 'Combined subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.576', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.080', 'groupDescription': 'This analysis pertains to the Inattention subscale at Visit 6.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'groupDescription': 'This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.077', 'groupDescription': 'This analysis pertains to the Combined Scale score at Visit 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The Swanson, Nolan, Pelham Rating Scale-Revised (SNAP-IV) includes 18 ADHD and 8 oppositional defiant disorder (ODD) symptoms. The symptoms are scored on a 4-point scale, not at all=0, just a little=1, Quite a bit= 2, very much=3. The ratings from the SNAP-IV scale are grouped into the following 4 subscales: ADHD Inattention (items #1-9), ADHD Hyperactivity/Impulsivity (items#10-18), ODD (items# 19-26), and ADHD-combined (first two scales combined, items #1-18). Each observed subscale score is the average rating of the items scores for the subscale where scores range from 0-3; the higher is the score, worsen is the outcome.\n\nData represent the change of the observed scores between Baseline (Visit 3) and the end of the study, Visit 6 (Week 5).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression Measured by the Percentage of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'OG001', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'classes': [{'title': '≥ 30% Responder', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': '≥ 50% Responder', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.93', 'groupDescription': 'This analysis pertains to ≥ 30% Responders.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6635', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.51', 'groupDescription': 'This analysis pertains to ≥ 50% Responders.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks', 'description': 'A Responder was defined as a subject with at least a 30% or 50% reduction in the frequency of IA behaviors per 7 days in the Treatment (Titration and Maintenance) period relative to the Baseline period per the IA Diary.\n\nData represent the percentage of subjects with 30% and 50% reduction in IA behaviors from Baseline to end of treatment period.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry. Based on the results of the 810P301 interim analysis, enrollment in the 18 mg of SPN-810 group was halted and subjects planned to receive the 18 mg dose in Stage 2 were randomly assigned to 36 mg of SPN-810 or placebo in a 2:1 ratio.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Subjects were randomized to receive Placebo twice each day (BID) with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'FG001', 'title': 'Low Dose SPN-810 (18 mg)', 'description': 'Oral\n\nSPN-810 (18 mg): Subjects were randomized to receive SPN-810 9 mg twice each day (BID) with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}, {'id': 'FG002', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Oral\n\nSPN-810 (36 mg): Subjects were randomized to receive SPN-810 18 mg twice each day (BID) with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'The number of subjects is based on the Safety Population which included all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'Intent-to-Treat', 'comment': 'The number of subjects is based on the Intent-to-Treat Population (ITT) which included all subjects who received at least 1 dose of study drug and have a baseline and at least 1 valid post-randomization assessment of frequency of IA behaviors based on IA diary entry.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'Modified Intent-to Treat', 'comment': 'The number of subjects is based on the Modified Intent-to-Treat Population (mITT) which included all subjects who received at least 1 dose of study drug and had a Baseline IA frequency ≥6 per week and at least 1 valid post-randomization assessment of frequency of IA behaviors based on IA diary entry.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'comment': 'Safety Population only', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal By Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other, Multiple categories', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects treated with a Placebo'}, {'id': 'BG001', 'title': 'Low Dose SPN-810 (18 mg)', 'description': 'Subjects treated with low dose of SPN-810'}, {'id': 'BG002', 'title': 'High Dose SPN-810 (36 mg)', 'description': 'Subjects treated with high dose of SPN-810'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '1.90', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '1.87', 'groupId': 'BG002'}, {'value': '9.1', 'spread': '1.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Retrospective-Modified Overt Aggression Scale (R-MOAS)', 'classes': [{'categories': [{'measurements': [{'value': '63.91', 'spread': '33.430', 'groupId': 'BG000'}, {'value': '66.38', 'spread': '27.894', 'groupId': 'BG001'}, {'value': '67.34', 'spread': '31.949', 'groupId': 'BG002'}, {'value': '66.06', 'spread': '31.637', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (a-d). For each open question in each area, the parent rates the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: 1(a), 4(b), 2(c) and 3(d). Therefore, the sum of each area yields a maximum weighted score of 20 (a), 120 (b), 60 (c), and 90 (c). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vitiello Aggression Scale', 'classes': [{'categories': [{'measurements': [{'value': '-3.32', 'spread': '1.089', 'groupId': 'BG000'}, {'value': '-3.20', 'spread': '1.129', 'groupId': 'BG001'}, {'value': '-3.48', 'spread': '1.153', 'groupId': 'BG002'}, {'value': '-3.37', 'spread': '1.130', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Vitiello Aggression Scale is a 10-item rating scale that uses a cluster analysis to categorize aggression into two subtypes; predatory and affective. The predatory score is calculated by summing up the individual scores from items 2, 5, 7, 9, and 10. The affective score is calculated by summing up the individual scores from items 1, 3, 4, 6, and 8. The total score is the difference of predatory score and affective score. Possible range of total score varies from 5 (completely predatory) to -5 (completely affective).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who received at least one dose of the study drug and have a baseline and at least one valid post-randomization assessment of the frequency of IA behaviors based on an IA diary entry.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-29', 'size': 28547762, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-10T17:48', 'hasProtocol': True}, {'date': '2020-01-21', 'size': 1061221, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-10T17:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2015-11-20', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary', 'timeFrame': 'Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks', 'description': 'The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.'}], 'secondaryOutcomes': [{'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S)', 'timeFrame': 'Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks.', 'description': "The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change between Baseline (Visit 3/Day 1) and three time points: Visit 4 (Week 1); Visit 5 (Week 2) and Visit 6 (Week 5)."}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated', 'timeFrame': 'Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks', 'description': "The Clinical Global Impression - Improvement Scale (CGI-I) is an assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of treatment.\n\nCGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse"}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28)', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The CHQ-PF28 is a short generic measure of health status and health-related quality of life. The 28 items have 4, 5, or 6 response options, divided over 8 multi-item scales (physical functioning, general behavior, mental health, self-esteem, general health perceptions, parental impact: emotional, parental impact: time, and family activities) and 5 single item concepts (role functioning: emotional/behavior, role functioning: physical, bodily pain, family cohesion, and change in health). In addition, the individual scale scores will be aggregated to derive 2 summary component scores: the physical functioning and psychosocial health summary scores. The range on subscales and the overall scale is 0-100 (0 = worst possible health state; 100 = best possible health state).\n\nData represent the change from Baseline (Visit 3) to one time point, Visit 6 (Week 5).'}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The PSI-4-SF is a 36-item self-report measure of parenting stress. Three subscales Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC) consist of 12 items each. Parent chooses one of the 5 responses against each item. The 5 responses are: Strongly Agree (SA), Agree (A), Not Sure (NS), Disagree (D), and Strongly Disagree (SD) to indicate the degree to which they agree with each statement. The PD subscale raw score ranges from 12-60, P-CDI and DC each subscale raw score ranges from 16-56. The total stress raw score is the sum of the three subscales (PD+P-CDI+ DC) with a minimum score of 44 and a maximum score of 172. The total stress score is then converted into the percentile score. Parents with a 91st percentile or higher are experiencing clinically significant levels of stress. Data represents the mean change in percentile score from Baseline (Visit 3) and one time point, Visit 6 (Week 5).'}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated', 'timeFrame': 'Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks', 'description': "The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subjects' global functioning prior to and after administration of a study medication. The scale was also rated by the Caregiver to assess the improvement of IA behaviors.\n\n. CGI-I was evaluated by the Caregiver at each visit on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse"}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale', 'timeFrame': 'Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.', 'description': 'The Swanson, Nolan, Pelham Rating Scale-Revised (SNAP-IV) includes 18 ADHD and 8 oppositional defiant disorder (ODD) symptoms. The symptoms are scored on a 4-point scale, not at all=0, just a little=1, Quite a bit= 2, very much=3. The ratings from the SNAP-IV scale are grouped into the following 4 subscales: ADHD Inattention (items #1-9), ADHD Hyperactivity/Impulsivity (items#10-18), ODD (items# 19-26), and ADHD-combined (first two scales combined, items #1-18). Each observed subscale score is the average rating of the items scores for the subscale where scores range from 0-3; the higher is the score, worsen is the outcome.\n\nData represent the change of the observed scores between Baseline (Visit 3) and the end of the study, Visit 6 (Week 5).'}, {'measure': 'Effect of SPN-810 on Impulsive Aggression Measured by the Percentage of Responders', 'timeFrame': 'Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks', 'description': 'A Responder was defined as a subject with at least a 30% or 50% reduction in the frequency of IA behaviors per 7 days in the Treatment (Titration and Maintenance) period relative to the Baseline period per the IA Diary.\n\nData represent the percentage of subjects with 30% and 50% reduction in IA behaviors from Baseline to end of treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder (ADHD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.', 'detailedDescription': 'This study is a randomized, placebo-controlled, double-blind, multicenter, parallel group, fixed dose study to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of IA in subjects aged 6 to 12 years with ADHD in conjunction with standard ADHD treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.\n* Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.\n* Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.\n* Known or suspected intelligence quotient (IQ) \\< 70, suicidality, pregnancy, or substance or alcohol abuse."}, 'identificationModule': {'nctId': 'NCT02618434', 'briefTitle': 'Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention Deficit/Hyperactivity Disorder in Conjunction With Standard ADHD Treatment', 'orgStudyIdInfo': {'id': '810P302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose SPN-810 (18 mg)', 'description': 'Oral', 'interventionNames': ['Drug: SPN-810 (18 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'High dose SPN-810 (36 mg)', 'description': 'Oral', 'interventionNames': ['Drug: SPN-810 (36 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPN-810 (18 mg)', 'type': 'DRUG', 'description': 'Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'armGroupLabels': ['Low dose SPN-810 (18 mg)']}, {'name': 'SPN-810 (36 mg)', 'type': 'DRUG', 'description': 'Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'armGroupLabels': ['High dose SPN-810 (36 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85226', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Metropolitan Neuro Behavioral Institute', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', 'facility': 'Sun Valley Research Center', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Alliance for Wellness dba Alliance for Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'ASCLEPES Research Center', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'MCB Clinical Research Centers, LLC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '20310', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center/Children's Research Institute", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Clinical Research Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33319', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Clinical Research, Inc', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '71103', 'city': 'North Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Laszlo J. 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