NCT00151970

Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Detailed description

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Methylphenidate Transdermal System	MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
DRUG	Placebo	Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
DRUG	Concerta	CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-09-09
• Last updated: 2015-07-09