Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT03597503
Status:
TERMINATED
Last Update Posted:
2024-04-24
First Post:
2018-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}}}, '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 Development', 'organization': 'Supernus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline/Visit 3 (Day 1) to Visit 8 (Day 46)-End of Study, a total of 46 days', 'description': 'Adverse events reporting pertains to the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day)', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 4, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'OG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.73', 'spread': '25.510', 'groupId': 'OG000'}, {'value': '-35.66', 'spread': '77.422', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) 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 7, 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 in IA behaviors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'OG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)', '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.\n\nData represent the change between Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'OG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}], 'classes': [{'title': 'VE Score Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': 'PH Score Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '9.55', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '12.62', 'groupId': 'OG001'}]}]}, {'title': 'PR Score Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': 'SE Score Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '10.46', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '16.53', 'groupId': 'OG000'}, {'value': '-21.9', 'spread': '19.22', 'groupId': 'OG001'}]}]}, {'title': 'VE Score Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '5.03', 'groupId': 'OG001'}]}]}, {'title': 'PH Score Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '12.34', 'groupId': 'OG001'}]}]}, {'title': 'PR Score Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'SE Score Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '7.88', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '9.09', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.8', 'spread': '23.37', 'groupId': 'OG000'}, {'value': '-34.9', 'spread': '25.76', 'groupId': 'OG001'}]}]}, {'title': 'VE Score Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'PH Score Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '11.00', 'groupId': 'OG001'}]}]}, {'title': 'PR Score Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '6.13', 'groupId': 'OG001'}]}]}, {'title': 'SE Score Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '6.30', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.7', 'spread': '32.21', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '15.41', 'groupId': 'OG001'}]}]}, {'title': 'VE Score Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '4.99', 'groupId': 'OG001'}]}]}, {'title': 'PH Score Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '13.89', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '9.51', 'groupId': 'OG001'}]}]}, {'title': 'PR Score Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'SE Score Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.2', 'spread': '29.99', 'groupId': 'OG000'}, {'value': '-32.3', 'spread': '15.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).', '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 (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH)=4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). 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.\n\nData represent the total score change between the Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29), and Visit 7 (Day 36).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'OG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}], 'classes': [{'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)', 'description': 'The treatment effect on the R-MOAS was assessed to capture the severity of the aggressive behaviors. The remission rate was defined as percentage of subjects with a R-MOAS total score ≤ 10.\n\nData represent the percentage of subjects at four time points during the treatment period: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: safety population is defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'FG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number of subjects is based on the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants underwent a 15-day baseline period (up to -Day 15), were randomized on Day 1 to receive either placebo or SPN-180, and then entered a 2- week titration phase followed by a 3-weeks maintenance phase, and then a 1-week taper phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects treated with Placebo'}, {'id': 'BG001', 'title': 'Flexible Dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '1.43', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '1.25', 'groupId': 'BG001'}, {'value': '13.1', 'spread': '1.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Participants is based on the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-01', 'size': 13544067, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-28T17:14', 'hasProtocol': True}, {'date': '2023-11-29', 'size': 620019, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-28T17:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Business decision, not related to safety', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2018-07-12', 'resultsFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-16', 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary', 'timeFrame': 'Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) 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 7, 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 (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)', 'timeFrame': 'From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)', '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.\n\nData represent the change between Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)."}, {'measure': 'Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score', 'timeFrame': 'From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).', '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 (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH)=4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). 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.\n\nData represent the total score change between the Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29), and Visit 7 (Day 36).'}, {'measure': 'Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate', 'timeFrame': 'Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)', 'description': 'The treatment effect on the R-MOAS was assessed to capture the severity of the aggressive behaviors. The remission rate was defined as percentage of subjects with a R-MOAS total score ≤ 10.\n\nData represent the percentage of subjects at four time points during the treatment period: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.', 'detailedDescription': 'This study was an addition to the pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD.\n\nSPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.\n* IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.\n\nExclusion Criteria:\n\n* History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.\n* Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.\n* Known or suspected intelligence quotient (IQ) \\<70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy."}, 'identificationModule': {'nctId': 'NCT03597503', 'briefTitle': 'Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment', 'orgStudyIdInfo': {'id': '810P503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible dose of SPN-810', 'description': 'Subjects treated with flexible dose of SPN-810', 'interventionNames': ['Drug: SPN-810']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects treated with Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPN-810', 'type': 'DRUG', 'description': 'Flexible dose', 'armGroupLabels': ['Flexible dose of SPN-810']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Neuropsychiatric Research Center of Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'MCB Clinical Research Centers, LLC', 'geoPoint': {'lat': 38.83388, 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