Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

Study Overview
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Brief Summary
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Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Detailed Description
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This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).

Official Title
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A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder

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: male or female aged 6-12 years females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline. a primary diagnosis of ADHD based on a detailed psychiatric evaluation a total score of =>26 on the ADHD-RS-IV at the Baseline Visit a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study. EXCLUSION CRITERIA: a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder a known non-responder to psychostimulant treatment overweight (Body Mass Index (BMI)-for-age >90th percentile) a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder. Conduct Disorder. Subject has taken an investigational drug within 30 days prior to Screening.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate Transdermal System<br>Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks | Drug: Methylphenidate Transdermal System<br>* The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA<br>* Other names: MTS;|
| Placebo Comparator: Placebo<br>Placebp matching MTS and Concerta for 7 weeks | Drug: Placebo<br>* The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA<br>* Other names: Sham treatment;|
| Active Comparator: Concerta<br>Methylphenidate HCL 18mg tablet 7 weeks | Drug: Concerta<br>* The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA<br>* Other names: Methylphenidate HCL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTRS-R, CPRS-R, CGI, PGA scores |  | 7 weeks | 
| Treatment emergent AEs, dermal evaluations, PK |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder (ADHD)