NCT00499863

Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of efficacy of MTS compared to placebo

Detailed description

To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	methylphenidate transdermal system	dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
DRUG	Placebo	Placebo patch

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-07-12
• Last updated: 2017-04-26
• Results posted: 2009-06-11

Locations

32 sites across 1 country: United States