Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy

Study Overview
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Brief Summary
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This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

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 safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Official Title
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A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Methylphenidate Transdermal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have a primary diagnosis of ADHD Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test Exclusion Criteria: A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually A recent history of suspected substance abuse or dependence disorder Subject is taking Strattera Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate Transdermal System<br>Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks | Drug: Methylphenidate Transdermal System<br>* To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo<br>* Other names: MTS;|
| Placebo Comparator: Placebo patch<br>Placebo patch applied daily for 8 weeks | Drug: Methylphenidate Transdermal System<br>* To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo<br>* Other names: MTS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on ADHD Rating Scale at 4 weeks |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent rating scale |  | 30 days | 
| Parent Global Assessment |  | 30 days | 
| Medication Satisfaction Survey |  | 30 days | 
| ADHD Impact Module |  | 30 days | 
| Clinical Global Impressions Scale |  | 30 days | 
| Adverse events, lab tests, dermal evaluations, ECGs |  | 30 days |