Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-07 @ 4:11 PM
Study NCT ID:
NCT00150592
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2005-09-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
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': 'D016316', 'term': 'Guanfacine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.', 'otherNumAtRisk': 121, 'otherNumAffected': 96, 'seriousNumAtRisk': 121, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 57, 'otherNumAffected': 32, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'spread': '63.11', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '64.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.844', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) defined as all subjects who completed the study and were deemed to be protocol-compliant.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '14.03', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '17.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.274', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Mean reaction time (adjusted) for each randomized treatment group at endpoint.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'title': 'Between errors', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.75', 'groupId': 'OG001'}]}]}, {'title': 'Within errors', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Double errors', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Strategy', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Between errors', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.552', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Within errors', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Double errors', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Strategy', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.8', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '7.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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': 'Full Analysis Set (FAS) defined as all subjects who received at least one dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', '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': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '5.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.231', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 182 subjects were enrolled. Four (4) subjects were terminated prior to receiving study medication. Thus, 178 were randomized and received study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SPD503', 'description': 'Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '178', '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': '12.6', 'spread': '2.83', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '2.77', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '2.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2005-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2005-09-06', 'resultsFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-09-11', 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.'}, {'measure': 'Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.'}, {'measure': 'Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.'}, {'measure': 'Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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': 'Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks', 'timeFrame': '6 weeks', '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': 'Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.'}, {'measure': 'Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '21476931', 'type': 'RESULT', 'citation': 'Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA recall information'}, {'url': 'http://www.intuniv.com/documents/INTUNIV_Full_Prescribing_Information.pdf', 'label': 'FDA-approved label'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a primary diagnosis of ADHD\n* Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =\\>4\n* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements\n* Subject weighs \\> 55 lbs and is not morbidly overweight\n\nExclusion Criteria:\n\n* Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders\n* Subject has a history of seizure disorder\n* Subject has any specific cardiac condition or family history of significant cardiac condition\n* Subject is pregnant, lactating or within six month post-partum'}, 'identificationModule': {'nctId': 'NCT00150592', 'briefTitle': 'Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD503-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPD503 (Guanfacine HCl)', 'interventionNames': ['Drug: SPD503 (Guanfacine HCl)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPD503 (Guanfacine HCl)', 'type': 'DRUG', 'armGroupLabels': ['SPD503 (Guanfacine HCl)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}