NCT00501293

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

A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Detailed description

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Methylphenidate Transdermal System	One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-07-16
• Last updated: 2017-04-26
• Results posted: 2010-01-15

Locations

32 sites across 1 country: United States