Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-03-06 @ 12:03 PM
Study NCT ID:
NCT02633527
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
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': 'jhull@supernus.com', 'phone': '240-403-5324', 'title': 'Joseph Hull, PhD, Director Clinical Research', 'organization': 'Supernus'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 Weeks', 'description': 'Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 23, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 22, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 30, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 30, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily'}, {'id': 'OG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '11.82', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '14.57', 'groupId': 'OG001'}, {'value': '-18.4', 'spread': '15.61', 'groupId': 'OG002'}, {'value': '-18.6', 'spread': '14.38', 'groupId': 'OG003'}, {'value': '-19.0', 'spread': '14.51', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0899', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0310', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '-0.7', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0268', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-15.3', 'ciUpperLimit': '-0.9', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0209', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '-1.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8 (End of Study)', 'description': 'The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\\<0) represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) assessment and have at least one post-baseline ADHD-RS-IV assessment'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily'}, {'id': 'OG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.25', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '1.13', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1376', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0090', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0546', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 8 (End of Study)', 'description': 'The first additional secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (End of Study). The CGI-I scale is a single item assessment of how much the patient\'s illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\\<4) in subsequent testing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) assessment and have at least one post-baseline ADHD-RS-IV assessment'}, {'type': 'SECONDARY', 'title': 'Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily'}, {'id': 'OG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'OG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '1.37', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '1.41', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0708', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0148', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0136', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8 (End of Study)', 'description': "The second additional secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale score at Week 8 (End of Study). The CGI-S scale is a single item clinician/investigator rating of the clinician's assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S was rated on a 7-point Likert scale, where 1 = Normal, not at all ill, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Extremely Ill. Successful therapy is indicated by a lower CGI-S score in subsequent testing. A lower change from baseline score (\\<0) represents a better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) assessment and have at least one post-baseline ADHD-RS-IV assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily'}, {'id': 'FG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'FG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'FG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'FG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Failed to meet eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '206', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Treatment A: Placebo was administered once daily'}, {'id': 'BG001', 'title': '100mg SPN-812', 'description': 'Treatment B: 100mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'BG002', 'title': '200mg SPN-812', 'description': 'Treatment C: 200mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'BG003', 'title': '300mg SPN-812', 'description': 'Treatment D: 300mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'BG004', 'title': '400mg SPN-812', 'description': 'Treatment E: 400mg SPN-812 was administered once daily and compared to placebo'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.89', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.78', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '1.95', 'groupId': 'BG002'}, {'value': '8.9', 'spread': '1.95', 'groupId': 'BG003'}, {'value': '9.0', 'spread': '2.18', 'groupId': 'BG004'}, {'value': '8.8', 'spread': '1.97', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '6 to 9 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}]}, {'title': '10 to 12 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '138', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '206', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ADHD RS-IV Total Score', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '7.76', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '6.82', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '7.45', 'groupId': 'BG002'}, {'value': '41.3', 'spread': '7.94', 'groupId': 'BG003'}, {'value': '40.8', 'spread': '7.87', 'groupId': 'BG004'}, {'value': '42.1', 'spread': '7.57', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Total score = sum of 18 items (range: 0 to 54). The higher the score, the more severe the ADHD symptoms (a total score \\>=26 was an inclusion criterion of this study).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ADHD RS-IV Inattention Subscale Score', 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '4.72', 'groupId': 'BG000'}, {'value': '22.1', 'spread': '3.86', 'groupId': 'BG001'}, {'value': '22.2', 'spread': '3.57', 'groupId': 'BG002'}, {'value': '21.8', 'spread': '3.75', 'groupId': 'BG003'}, {'value': '21.0', 'spread': '4.71', 'groupId': 'BG004'}, {'value': '21.8', 'spread': '4.06', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to 18 ADHD symptoms per DSM-IV, including 9 items for the Hyperactivity/Impulsivity (HI) subscale and 9 items for the Inattention (IA) subscale. Each item is rated on a 4-point Likert-type scale from (0=never or rarely to 3=very often). The IA Subscale score = sum of all 9 IA items on the ADHD-RS-IV (range:0 to 27). The higher the score, the more severe the IA symptoms of ADHD.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ADHD RS-IV Hyperactivity/ Impulsivity Subscale Score', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '4.40', 'groupId': 'BG000'}, {'value': '20.3', 'spread': '5.15', 'groupId': 'BG001'}, {'value': '21.7', 'spread': '5.10', 'groupId': 'BG002'}, {'value': '19.4', 'spread': '5.99', 'groupId': 'BG003'}, {'value': '19.7', 'spread': '4.43', 'groupId': 'BG004'}, {'value': '20.3', 'spread': '5.14', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. It consists of 18 items that correspond to 18 ADHD symptoms per DSM-IV, including 9 items for the Hyperactivity/Impulsivity (HI) subscale and 9 items for the Inattention (IA) subscale. Each item is rated on a 4-point Likert-type scale from (0=never or rarely to 3=very often). The HI Subscale score = sum of all 9 HI items on the ADHD-RS-IV (range:0 to 27). The higher the score, the more severe the HI symptoms of ADHD.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) assessment, and have at least one post-baseline ADHD-RS-IV assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2020-08-11', 'completionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2015-12-15', 'dispFirstSubmitQcDate': '2020-08-11', 'resultsFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2015-12-15', 'dispFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-29', 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)', 'timeFrame': 'Baseline to Week 8 (End of Study)', 'description': 'The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\\<0) represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale', 'timeFrame': 'Week 8 (End of Study)', 'description': 'The first additional secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (End of Study). The CGI-I scale is a single item assessment of how much the patient\'s illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\\<4) in subsequent testing.'}, {'measure': 'Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale', 'timeFrame': 'Baseline to Week 8 (End of Study)', 'description': "The second additional secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale score at Week 8 (End of Study). The CGI-S scale is a single item clinician/investigator rating of the clinician's assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S was rated on a 7-point Likert scale, where 1 = Normal, not at all ill, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Extremely Ill. Successful therapy is indicated by a lower CGI-S score in subsequent testing. A lower change from baseline score (\\<0) represents a better outcome."}]}, 'conditionsModule': {'conditions': ['Attention-Deficit/Hyperactivity Disorder (ADHD)']}, 'descriptionModule': {'briefSummary': 'This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).\n2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.\n3. CGI-S score of at least 4\n4. Weight of at least 20 kg.\n5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.\n\nExclusion Criteria:\n\n1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.\n2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.\n3. Significant systemic disease.\n4. Evidence of suicidality within the six months before Screening or at Screening.\n5. BMI greater than 95th percentile for the appropriate age and gender.\n6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).\n7. Substance or alcohol use during the last three months.\n8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening."}, 'identificationModule': {'nctId': 'NCT02633527', 'briefTitle': 'Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study', 'orgStudyIdInfo': {'id': '812P202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, qd, oral capsule', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '100mg SPN-812', 'description': '100mg SPN-812, qd, oral capsule', 'interventionNames': ['Drug: 100mg SPN-812']}, {'type': 'EXPERIMENTAL', 'label': '200mg SPN-812', 'description': '200mg SPN-812, qd, oral capsule', 'interventionNames': ['Drug: 200mg SPN-812']}, {'type': 'EXPERIMENTAL', 'label': '300mg SPN-812', 'description': '300mg SPN-812, qd, oral capsule', 'interventionNames': ['Drug: 300mg SPN-812']}, {'type': 'EXPERIMENTAL', 'label': '400mg SPN-812', 'description': '400mg SPN-812, qd, oral capsule', 'interventionNames': ['Drug: 400mg SPN-812']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PBO'], 'description': 'Placebo was administered once daily', 'armGroupLabels': ['Placebo']}, {'name': '100mg SPN-812', 'type': 'DRUG', 'otherNames': ['SPN-812, Low Dose'], 'description': '100mg SPN-812 was administered once daily and compared to placebo', 'armGroupLabels': ['100mg SPN-812']}, {'name': '200mg SPN-812', 'type': 'DRUG', 'otherNames': ['SPN-812, Low-Medium Dose'], 'description': '200mg SPN-812 was administered once daily and compared to placebo', 'armGroupLabels': ['200mg SPN-812']}, {'name': '300mg SPN-812', 'type': 'DRUG', 'otherNames': ['SPN-812, Medium-High Dose'], 'description': '300mg SPN-812 was administered once daily and compared to placebo', 'armGroupLabels': ['300mg SPN-812']}, {'name': '400mg SPN-812', 'type': 'DRUG', 'otherNames': ['SPN-812, High Dose'], 'description': '400mg SPN-812 was administered once daily and compared to placebo', 'armGroupLabels': ['400mg SPN-812']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}], 'overallOfficials': [{'name': 'Joseph T. Hull, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supernus Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}