Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 7:47 AM
Study NCT ID:
NCT00989950
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'ashkenasi1@gmail.com', 'phone': '011 972 50 3007477', 'title': 'Arie Ashkenasi, MD', 'organization': 'CoxHealth'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size, did not permit an examination of more specific differences among patch wear time conditions. Small sample size resulted in weaker randomization to patch wear time sequences that was not completely balanced in baseline covariates.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group Sequence 1', 'description': 'Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group Sequence 2', 'description': 'Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group Sequence 3', 'description': 'Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group Sequence 4', 'description': 'Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '9 hr Wear', 'description': 'Result for all patients when patch worn for 9 hrs/day'}, {'id': 'OG001', 'title': '10 hr Wear', 'description': 'Result for all patients when patch worn for 10 hrs/day'}, {'id': 'OG002', 'title': '11 hr Wear', 'description': 'Result for all patients when patch worn for 11 hrs/day'}, {'id': 'OG003', 'title': '12 hr Wear', 'description': 'Result for all patients when patch worn for 12 hrs/day'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '41'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '42'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '34', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '42'}]}]}], 'analyses': [{'pValue': '0.588', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0', 'ciUpperLimit': '233', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '9 weeks', 'description': 'Measure by daily subject sleep diary', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Sequence 1', 'description': 'Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'FG001', 'title': 'Group Sequence 2', 'description': 'Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'FG002', 'title': 'Group Sequence 3', 'description': 'Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'FG003', 'title': 'Group Sequence 4', 'description': 'Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}], 'periods': [{'title': 'Open Label Dose Optimization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Sequence 1', 'description': 'Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'BG001', 'title': 'Group Sequence 2', 'description': 'Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'BG002', 'title': 'Group Sequence 3', 'description': 'Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'BG003', 'title': 'Group Sequence 4', 'description': 'Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Attention Deficit Hyperactivity Disorder (ADHD) Subtype', 'classes': [{'title': 'Combined Subtype', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Other Subtype', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'There are 3 subtypes of ADHD as defined by the DSM-IV-TR. Inattentive, Hyperactive/Impulsive and combined subtype (hyperactive/impulsive and inattentive). "Other subtype" refers to individuals who are not of the combined subtype but instead are either hyperactive/impulsive or inattentive type.', 'unitOfMeasure': 'participants'}, {'title': "Conner's Global Impression-Parent Scale", 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '20.1', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '25', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '20.3', 'spread': '6.7', 'groupId': 'BG003'}, {'value': '19.78', 'spread': '6.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Rating scale filled out by the parents/caregivers. Scale consists of 28 questions divided into four subscales of oppositional problems, cognitive problems, hyperactivity and an ADHD index. Questions scored on a 4 point scale (0-3; 84 points possible), where a higher score indicates more severe symptom presentation.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Attention Deficit Hyperactivity Disorder Rating Scale-IV Total Score', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '11', 'groupId': 'BG000'}, {'value': '37', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '41', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '33.7', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '34.7', 'spread': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'An 18-item scale corresponding to the 18 items in the DSM-IV-TR that is divided into two subsclaes: hyperactivity/impulsivity and inattentiveness. Items scored on a 4-point frequency scale ranging from 0=never/rarely to 3=very often; 54 points possible with higher score indicating more severe symptoms. Rating scale is filled out by the caregiver.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sleep Latency', 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '23.3', 'spread': '21.8', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '64.8', 'groupId': 'BG002'}, {'value': '50.7', 'spread': '12.4', 'groupId': 'BG003'}, {'value': '37.8', 'spread': '27.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Sleep latency was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality)', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Sleep Time', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '.9', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '.9', 'groupId': 'BG001'}, {'value': '10.6', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '9.6', 'spread': '1.8', 'groupId': 'BG003'}, {'value': '9.9', 'spread': '1.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Total sleep time was taken by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality)', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sleep Quality', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '.8', 'groupId': 'BG000'}, {'value': '4', 'spread': '1', 'groupId': 'BG001'}, {'value': '4', 'spread': '.8', 'groupId': 'BG002'}, {'value': '3.1', 'spread': '.7', 'groupId': 'BG003'}, {'value': '3.9', 'spread': '.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Sleep quality was documented by patient diary which included questions for the caregiver and patient to answer together regarding sleep patterns (time to sleep, duration of sleep, night awakenings, sleep quality). Assessed on a 5 point scale (0-lowest quality; 5-highest quality)', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2009-09-30', 'resultsFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-15', 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Latency', 'timeFrame': '9 weeks', 'description': 'Measure by daily subject sleep diary'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['daytrana', 'sleep latency', 'adhd rating scales', 'ADHD'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'INSOMNIA']}, 'referencesModule': {'references': [{'pmid': '22115000', 'type': 'RESULT', 'citation': 'Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.'}]}, 'descriptionModule': {'briefSummary': 'Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.', 'detailedDescription': 'Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.\n\n25 patients will be enrolled in order to obtain statistical significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ADHD without significant comorbidity\n\nExclusion Criteria:\n\n* Cardiac disorder\n* Hypertension\n* Thyroid disease\n* Glaucoma\n* History of sudden death, motor tics and/or Tourette's syndrome\n* Hypersensitivity to methylphenidate"}, 'identificationModule': {'nctId': 'NCT00989950', 'acronym': 'Daytsleep', 'briefTitle': 'Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Cox Health Systems'}, 'officialTitle': 'Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'cox002'}, 'secondaryIdInfos': [{'id': 'shire IND#54,732', 'type': 'OTHER', 'domain': 'Shire Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daytrana 9 hr wear', 'interventionNames': ['Drug: Daytrana']}, {'type': 'EXPERIMENTAL', 'label': 'Daytrana 10 hr wear', 'interventionNames': ['Drug: Daytrana']}, {'type': 'EXPERIMENTAL', 'label': 'Daytrana 11 hr wear', 'interventionNames': ['Drug: Daytrana']}, {'type': 'EXPERIMENTAL', 'label': 'Daytrana 12 hr wear', 'interventionNames': ['Drug: Daytrana']}], 'interventions': [{'name': 'Daytrana', 'type': 'DRUG', 'otherNames': ['methylphenidate transdermal system'], 'description': 'Daytrana patch 10-30 mg administered once daily for 9hr', 'armGroupLabels': ['Daytrana 9 hr wear']}, {'name': 'Daytrana', 'type': 'DRUG', 'otherNames': ['methylphenidate transdermal system'], 'description': 'Daytrana 10-30 mg worn once daily for 10 hr wear', 'armGroupLabels': ['Daytrana 10 hr wear']}, {'name': 'Daytrana', 'type': 'DRUG', 'otherNames': ['methylphenidate transdermal system'], 'description': 'Daytrana 10-30 mg worn once daily for 11 hr', 'armGroupLabels': ['Daytrana 11 hr wear']}, {'name': 'Daytrana', 'type': 'DRUG', 'description': 'Daytrana 10-30 mg worn once daily for 12 hrs', 'armGroupLabels': ['Daytrana 12 hr wear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pediatric Neurology of the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'arie ashkenasi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pediatric neurology of the ozarks'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cox Health Systems', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Neurologist', 'investigatorFullName': 'Arie Ashkenasi, MD', 'investigatorAffiliation': 'Cox Health Systems'}}}}