Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT00141050
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D064699', 'term': 'Dexmethylphenidate Hydrochloride'}], 'ancestors': [{'id': 'D008774', 'term': 'Methylphenidate'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-17', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in attention and deportment measured at 2 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose'}, {'measure': "Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline"}, {'measure': 'Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.'}]}, 'conditionsModule': {'keywords': ['ADHD, children'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of ADHD\n* Males and females aged 6-12\n\nExclusion Criteria:\n\n* Inability to understand or follow instructions\n* Is pregnant\n* Diagnosis of tic disorder\n* History of seizure disorder'}, 'identificationModule': {'nctId': 'NCT00141050', 'briefTitle': 'Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD', 'orgStudyIdInfo': {'id': 'CRIT124EUS12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Focalin XR', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77007', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Bayou City Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Matthew Brams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bayou City Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}