Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
NCT ID: NCT00466791
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2004-08-31
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Methylphenidate Transdermal System
Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks
Methylphenidate Transdermal System
Placebo
Placebo
Transdermal patch, 0mg, daily for 11 weeks
Methylphenidate Transdermal System
Placebo
Interventions
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Methylphenidate Transdermal System
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Total score of greater than or equal to 26 on ADHD-RS-IV
* IQ of greater than or equal to 80
* Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline
Exclusion Criteria
* Known nonresponder to psychostimulant treatment
* BMI for age greater than 90th percentile
* History of seizures during last 2 years
* Conduct Disorder
6 Years
12 Years
ALL
No
Sponsors
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Noven Therapeutics
INDUSTRY
Responsible Party
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Locations
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UCI Child Development Center
Irvine, California, United States
Countries
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References
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McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85. doi: 10.1177/1087054705284089.
Related Links
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FDA-approved labelling information, US only
FDA Recall information
Other Identifiers
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SPD485-201
Identifier Type: -
Identifier Source: org_study_id
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