Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-03 @ 3:47 PM
Study NCT ID:
NCT00501293
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2007-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years 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'}]}, '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': 'twhitaker@shire.com', 'title': 'Timothy Whitaker, MD', 'organization': 'Shire Pharmaceutical'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population defined as all subjects who received at least one dose of MTS.', 'eventGroups': [{'id': 'EG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.', 'otherNumAtRisk': 109, 'otherNumAffected': 36, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.', 'otherNumAtRisk': 53, 'otherNumAffected': 32, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '16.0', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '13.5', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '9.53', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 months', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '11.80', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '15.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of MTS at baseline and 6 months'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of placebo at baseline and 6 months'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '26.5', 'spread': '18.22', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '16.94', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '22.5', 'spread': '16.68', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '12.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 months', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '-17.7', 'spread': '20.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of MTS at baseline and 6 months'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of placebo at baseline and 6 months'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '82.4', 'spread': '14.28', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '14.61', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '85.0', 'spread': '13.00', 'groupId': 'OG000'}, {'value': '84.6', 'spread': '10.78', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 months', 'categories': [{'measurements': [{'value': '1.9', 'spread': '9.57', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '6.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of MTS at baseline and 6 months'}, {'pValue': '0.017', 'groupIds': ['OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 't-test of placebo at baseline and 6 months'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Not all subjects in the ITT population completed a YQOL-R.'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '113.4', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '113.0', 'spread': '11.20', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '115.3', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '115.9', 'spread': '14.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as all subjects that received at least one dose of MTS.'}, {'type': 'PRIMARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '69.4', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '7.69', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '67.9', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '68.9', 'spread': '8.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '80.4', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '9.73', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '81.7', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '12.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Electrocardiogram Results (QTcF Interval)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '391.8', 'spread': '20.76', 'groupId': 'OG000'}, {'value': '393.2', 'spread': '17.85', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '395.3', 'spread': '21.22', 'groupId': 'OG000'}, {'value': '393.5', 'spread': '21.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.", 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Post Sleep Questionnaire (PSQ) Quality of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Very poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Average', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Very Good', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'OG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'classes': [{'title': 'Baseline measure', 'categories': [{'measurements': [{'value': '127.05', 'spread': '24.003', 'groupId': 'OG000'}, {'value': '131.95', 'spread': '29.862', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '134.55', 'spread': '25.575', 'groupId': 'OG000'}, {'value': '124.78', 'spread': '29.083', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'lb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Dermal Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Antecedent MTS and Antecedent Placebo', 'description': 'Methylphenidate Transdermal System and Placebo Patch'}], 'classes': [{'title': '0 (No evidence of irritation)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '1 (Minimal erythema)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': '2 (Definite erythema)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': '3 (Erythema and papules)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '4 (Definite edema)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '5 (Erythema, edema, and papules)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '6 (Vesicular eruption)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '7 (Strong reaction beyond test site)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No dermal evaluation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'FG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}], 'periods': [{'title': 'Optimization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Enrolled in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliant with study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Went into rehabilitation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Would not wear patch', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Application site reaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Open-label, extension study of Methylphenidate Transdermal System (MTS) in subjects who had previously received study medication (MTS or placebo) in the antecedent study, SPD485-409 (NCT00499863). Upon entry into this study (SPD485-410), all subjects received MTS treatment regardless of the study treatment they had received in study SPD485-409.', 'preAssignmentDetails': 'The study consisted of a dose optimization period (approx. 5 weeks) and a maintenance period (5 months). Methylphenidate Transdermal System (MTS)(10, 15, 20 or 30 mg / 9 hour dose patch) was applied once-daily on the alternating hip for a 9-hour wear time. One subject in the MTS group was enrolled in error and was removed prior to receiving drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Antecedent Methylphenidate Transdermal System (MTS)', 'description': 'Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'BG001', 'title': 'Antecedent Placebo', 'description': 'Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '1.18', 'groupId': 'BG000'}, {'value': '14.5', 'spread': '1.37', 'groupId': 'BG001'}, {'value': '14.5', 'spread': '1.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2007-07-12', 'resultsFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-12-10', 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Pulse Rate', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Electrocardiogram Results (QTcF Interval)', 'timeFrame': 'Baseline and 6 months', 'description': "QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation."}, {'measure': 'Post Sleep Questionnaire (PSQ) Quality of Sleep', 'timeFrame': '6 months', 'description': 'Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.'}, {'measure': 'Weight', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Dermal Reactions', 'timeFrame': '6 months', 'description': 'Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.'}, {'measure': "Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months", 'timeFrame': 'Baseline and 6 months', 'description': "The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior."}, {'measure': 'Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores', 'timeFrame': '6 months', 'description': 'Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.'}, {'measure': 'Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.', 'timeFrame': '6 months', 'description': 'Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.'}, {'measure': 'Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'referencesModule': {'references': [{'pmid': '20973707', 'type': 'RESULT', 'citation': 'Findling RL, Katic A, Rubin R, Moon E, Civil R, Li Y. A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):365-75. doi: 10.1089/cap.2009.0122.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD', 'detailedDescription': 'To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:\n\n* The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.\n* Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.\n* Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.\n* Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.\n* Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.\n* Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.\n* There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.\n\nExclusion Criteria\n\nSubjects will be excluded from the study if any of the following criteria are met at Entry:\n\n* Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).\n* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.\n* Subject is taking any medication that is excluded.\n* Female subject who is pregnant or lactating."}, 'identificationModule': {'nctId': 'NCT00501293', 'briefTitle': 'Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noven Therapeutics'}, 'officialTitle': 'A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD485-410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Methylphenidate Transdermal System', 'interventionNames': ['Drug: Methylphenidate Transdermal System']}], 'interventions': [{'name': 'Methylphenidate Transdermal System', 'type': 'DRUG', 'otherNames': ['DAYTRANA'], 'description': 'One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Melmed Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Research Institute', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'facility': 'Elite Clinical Trials Inc.', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarkis Clinical Trials'}, {'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Behavioral Research Ctr', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mountain West Clinical Trials, LLC', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Shire Clinical Research Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Four Rivers Clinical Research, Inc.', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'city': 'Rochester Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Rochester Center for Behavioral Medicine', 'geoPoint': {'lat': 42.65837, 'lon': 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'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon center for Clinical Investigations, Inc.', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OCCI, Inc', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shire Clinical Research Site', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CRI Worldwide', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CNS Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Claghorn-Lesem Research, Ltd.', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Westex Clinical Investigations', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cerebral Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Clinical Study Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Herndon', 'state': 'Virginia', 'country': 'United States', 'facility': 'NeuroScience, Inc.', 'geoPoint': {'lat': 38.96955, 'lon': -77.3861}}, {'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Adolescent Health Center', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'city': 'Friday Harbor', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 48.53427, 'lon': -123.01712}}, {'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastside Therapeutic Resource', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'overallOfficials': [{'name': 'Robert L. Findling, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noven Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}