Trial | NCT00466791  Report issue

Title

Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    methylphenidate ...

  • Study Participants

    93
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
Study Started
Aug 31
2004
Primary Completion
May 31
2005
Study Completion
May 31
2005
Last Update
Jun 25
2015
Estimate

Drug Methylphenidate Transdermal System

Placebo

  • Other names: ADHD Patch

Methylphenidate Transdermal System Active Comparator

Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks

Placebo Placebo Comparator

Transdermal patch, 0mg, daily for 11 weeks

Criteria 

Inclusion Criteria:

Primary diagnosis ADHD
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:

Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
Known nonresponder to psychostimulant treatment
BMI for age greater than 90th percentile
History of seizures during last 2 years
Conduct Disorder
No Results Posted