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)
Overview
- Phase
- Phase 2
- Intervention
- Methylphenidate Transdermal System
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Noven Therapeutics
- Enrollment
- 128
- Primary Endpoint
- SKAMP deportment rating scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects have primary diagnosis of ADHD
- •Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- •Subject has an IQ score of \>_ 80
- •Subject is able to complete as least the Basic Test of the PERMP assessment
Exclusion Criteria
- •Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- •Subject is taking Strattera(r)
- •Subject has a recent history of suspected substance abuse or dependence disorder
Arms & Interventions
Methylphenidate Transdermal System
The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.
Intervention: Methylphenidate Transdermal System
Placebo
The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.
Intervention: Placebo
Concerta
CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
Intervention: Concerta
Outcomes
Primary Outcomes
SKAMP deportment rating scale
Time Frame: Week 8
Secondary Outcomes
- Clinician-rated ADHD-RS-IV(Week 8)
- Parent Global Assessment(Week 8)
- ADHD Impact Module-Children(Week 8)
- PERMP age-adjusted math test(Week 8)
- CGI-I(Week 8)
- Connors' Parent Rating Scale(Week 8)
- SKAMP-total and inattention subscales(Week 8)