Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Phase 2
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Registration Number
- NCT00466791
- Lead Sponsor
- Noven Therapeutics
- Brief Summary
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
- Detailed Description
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Methylphenidate Transdermal System Methylphenidate Transdermal System Transdermal patch, 27.5mg, 41.3mg, 55mg, and 82.5mg, daily for 11 weeks Placebo Methylphenidate Transdermal System Transdermal patch, 0mg, daily for 11 weeks
- Primary Outcome Measures
Name Time Method Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS 2,3,4.5,6,7.5,9,10.5 and 12 hours
- Secondary Outcome Measures
Name Time Method PERMP scores pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application Clinician-rated ADHD-RS-IV score 2,3,4.5,6,7.5,9,10.5 and 12 hours CGI-I score Weeks 1-9 CPRS-R score Weeks 1-9 PGA Weeks 1-9
Trial Locations
- Locations (1)
UCI Child Development Center
🇺🇸Irvine, California, United States