Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 6:34 PM
Study NCT ID:
NCT04507204
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-24', '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaromir.mikl@pharma.com', 'phone': '800-745-7445', 'title': 'Jaromir Mikl, PhD MSPH', 'phoneExt': '7277', 'organization': 'Purdue Pharma L.P.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were reported starting from the time informed consent for study participation up to 6 months.', 'description': 'Since participants may have received multiple dose levels during the study and a participant may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.', 'eventGroups': [{'id': 'EG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 28, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 27, 'seriousNumAtRisk': 134, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}], 'classes': [{'title': 'Total Score at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '8.60', 'groupId': 'OG000'}]}]}, {'title': 'Total Score at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.7', 'spread': '9.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month-2', 'description': 'The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month-2', 'description': 'TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Clinical Global Impression-Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month-2, Month-4, and Month-6', 'description': 'The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Clinical Global Impression-Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month-2, Month-4, and Month-6', 'description': 'The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Global Satisfaction at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.8', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.2', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Global Satisfaction at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.3', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '52.4', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.1', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Effectiveness at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.9', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '61.9', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '67.6', 'spread': '3.24', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': 'Convenience at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.9', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Convenience at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Convenience at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '2.13', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month-1, Month-2, and Month-6', 'description': "The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.\n\nA lower score indicates a lower satisfaction with treatment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Baseline (past 6 months) Overall Total Visits or Inpatient Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.314', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '0.314', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 - Overall Total Visits or Inpatient Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.481', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 - Overall Total Visits or Inpatient Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.474', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.504', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 - Overall Total Visits or Inpatient Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.515', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.480', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (past 6 months) Months -2, -4, and -6', 'description': 'A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.', 'unitOfMeasure': 'Visits or Inpatient Admissions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Adult ADHD Quality of Life Scale - Revised (AAQoL-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Total Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.5', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.0', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '59.1', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.3', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Total Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.4', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months -1, -2, -3, -4, -5 and -6', 'description': 'Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment (WPAI) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Percent work time missed due to health (Absenteeism) - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Percent work time missed due to health (Absenteeism) - Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Percent work time missed due to health (Absenteeism) - Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Percent work time missed due to health (Absenteeism) - Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Percent work time missed due to health (Absenteeism) - Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Percent work time missed due to health (Absenteeism) - Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.0', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '2.90', 'groupId': 'OG001'}]}]}, {'title': 'Percent impairment while working due to health (Presenteeism) - Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.9', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.1', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '3.17', 'groupId': 'OG001'}]}]}, {'title': 'Percent overall work impairment due to health - Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.7', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '40.9', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Percent activity impairment due to health - Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months -2, -3, -4, -5, and -6', 'description': 'The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains \\[absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)\\]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.', 'unitOfMeasure': 'percentage of impairment', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'OG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'classes': [{'title': 'Global PSQI - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.68', 'spread': '0.219', 'groupId': 'OG000'}, {'value': '9.59', 'spread': '0.209', 'groupId': 'OG001'}]}]}, {'title': 'Global PSQI - Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.92', 'spread': '0.251', 'groupId': 'OG000'}, {'value': '9.59', 'spread': '0.209', 'groupId': 'OG001'}]}]}, {'title': 'Global PSQI - Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.11', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '7.76', 'spread': '0.252', 'groupId': 'OG001'}]}]}, {'title': 'Global PSQI - Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.92', 'spread': '0.284', 'groupId': 'OG000'}, {'value': '7.80', 'spread': '0.273', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Months -2, -4, and -6', 'description': 'The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates "poor" from "good" sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'FG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Poor Compliance with Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other (e.g., PI judgment, moved out of state. etc.)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal of Patient Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'First patient first visit was 30-Jul-2020; primary completion date was 22-Dec-2021 (i.e., the adult portion was completed). This study was statistically powered to conduct a separate analysis for adult and adolescent patients. However, enrollment of adolescents was unexpectedly slow as a result of the Coronavirus Disease 2019 (COVID-19) pandemic and a business decision was made on 31-Jan-2022 to discontinue enrollment of adolescents, thus terminating this branch of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adhansia XR', 'description': 'Methylphenidate extended-release capsules taken once daily.'}, {'id': 'BG001', 'title': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-14', 'size': 507723, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-08T12:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'whyStopped': '(due to administrative reasons not related to efficacy or safety.)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2020-07-24', 'resultsFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-07', 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR', 'timeFrame': 'Baseline to Month-2', 'description': 'The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.'}], 'secondaryOutcomes': [{'measure': 'Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority', 'timeFrame': 'Month-2', 'description': 'TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.'}, {'measure': 'Assessment of Clinical Global Impression-Severity (CGI-S)', 'timeFrame': 'Baseline, Month-2, Month-4, and Month-6', 'description': 'The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.'}, {'measure': 'Assessment of Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': 'Month-2, Month-4, and Month-6', 'description': 'The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.'}, {'measure': 'Assessment of Treatment Satisfaction', 'timeFrame': 'Month-1, Month-2, and Month-6', 'description': "The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.\n\nA lower score indicates a lower satisfaction with treatment."}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': 'Baseline (past 6 months) Months -2, -4, and -6', 'description': 'A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.'}, {'measure': 'Adult ADHD Quality of Life Scale - Revised (AAQoL-R)', 'timeFrame': 'Baseline, Months -1, -2, -3, -4, -5 and -6', 'description': 'Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.'}, {'measure': 'Work Productivity and Activity Impairment (WPAI) Questionnaire', 'timeFrame': 'Baseline, Months -2, -3, -4, -5, and -6', 'description': 'The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains \\[absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)\\]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.'}, {'measure': 'Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline and Months -2, -4, and -6', 'description': 'The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates "poor" from "good" sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Methylphenidate', 'Adhansia XR', 'MPH', 'OROS', 'Phase IV'], 'conditions': ['Attention-Deficit/Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '35201607', 'type': 'DERIVED', 'citation': 'Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.', 'detailedDescription': 'This phase IV study is a prospective, open-label, randomized, pragmatic study to investigate the treatment effectiveness of Adhansia XR at Month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (OROS MPH or Concerta) over time. Additional outcome assessments for both treatment arms include Health-Related Quality of Life (HRQoL) during the 6-month follow-up period. The burden of illness (BOI) will be investigated by collecting additional measures such as healthcare resource utilization (HCRU), broader treatment patterns, and comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has made the decision to prescribe an extended-release methylphenidate (ER MPH) product to the patient for potential improvement of symptoms throughout and later in the day, independent of this study.\n* Patient must be 12 years of age or older.\n* Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery system methylphenidate (\\[OROS MPH\\] or Concerta) according to the US product labels; a patient must be eligible and willing to receive either drug, as randomization will assign them to a specific treatment group. Patient may be treatment-experienced or naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion criteria are met.\n* Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study (i.e. full titration period). Patients should not be on any other medication, or starting any new non-medication treatment, proven to have effect on ADHD in the first two months of the study.\n\nExclusion Criteria:\n\n* Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol.\n* Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known to be non-responsive to MPH or AMP treatment.\n* Patient is currently stable on their ADHD treatment regimen.\n* Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding.\n* Patient with any known conditions that are contraindicated for either Adhansia XR or OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information, including patients with any known serious structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.\n* Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and Cosmetic Yellow No. 5).\n* Suicidal Ideation\n\n * The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at screening and at Month-2, Month-4, and Month-6, but also depends on the judgment of the HCP.\n* Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means.'}, 'identificationModule': {'nctId': 'NCT04507204', 'acronym': 'RE-DAX', 'briefTitle': 'Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States', 'orgStudyIdInfo': {'id': 'ADA4003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adhansia XR', 'description': 'Adhansia XR capsules taken orally once daily with or without food.', 'interventionNames': ['Drug: Adhansia XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concerta', 'description': 'Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.', 'interventionNames': ['Drug: Concerta']}], 'interventions': [{'name': 'Adhansia XR', 'type': 'DRUG', 'otherNames': ['Methylphenidate hydrochloride (HCl) extended release'], 'description': 'Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)', 'armGroupLabels': ['Adhansia XR']}, {'name': 'Concerta', 'type': 'DRUG', 'otherNames': ['Methylphenidate hydrochloride (HCl)'], 'description': 'An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)', 'armGroupLabels': ['Concerta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Harmonex, Inc.', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research LLC', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CT Clinical Research', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'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': 'Reliable Clinical Research, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Eastern Research. 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