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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Methylphenidate Transdermal System
* Drug: Placebo
* Drug: Concerta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate Transdermal System<br>The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening. | Drug: Methylphenidate Transdermal System<br>* MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes<br>* Other names: MTS;|
| Placebo Comparator: Placebo<br>The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening. | Drug: Placebo<br>* Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily<br>* Other names: Sham Treatment;|
| Active Comparator: Concerta<br>CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily | Drug: Concerta<br>* CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily<br>* Other names: Methylphenidate HCL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKAMP deportment rating scale |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERMP age-adjusted math test |  | Week 8 | 
| Clinician-rated ADHD-RS-IV |  | Week 8 | 
| CGI-I |  | Week 8 | 
| Parent Global Assessment |  | Week 8 | 
| Connors' Parent Rating Scale |  | Week 8 | 
| ADHD Impact Module-Children |  | Week 8 | 
| SKAMP-total and inattention subscales |  | Week 8 |