Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

Study Overview
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Brief Summary
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To assess the efficacy and safety of efficacy of MTS compared to placebo

Detailed Description
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To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.

Official Title
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A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD

Conditions
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ADHD

Intervention / Treatment
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* Drug: methylphenidate transdermal system
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation. Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2). Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline. Subject is a male or female aged 13 17 years. Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP. Exclusion Criteria: Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder. Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention. Subject is overweight. Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder. Subject has Conduct Disorder. Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any). Subject has a history of alcohol or other substance abuse or dependence. Subject has taken an investigational drug within 30 days prior to screening. Subject has any abnormal thyroid function. Subject has any clinically significant laboratory abnormalities. Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary. The female subject is pregnant or lactating. Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis). Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives. Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: Methylphenidate Transdermal System<br>dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear | Drug: methylphenidate transdermal system<br>* dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear<br>* Other names: DAYTRANA;|
| Placebo Comparator: 2<br>Daily application of matching MTS Placebo Patch | Drug: Placebo<br>* Placebo patch<br>* Other names: Sham treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | baseline and endpoint (up to 7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). | Baseline and endpoint (up to 7 weeks) | 
| Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | up to 7 weeks | 
| Improvement in Parent Global Assessment (PGA) Score | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | up to 7 weeks | 
| Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). | Baseline and endpoint (up to 7 weeks) | 
| Dermal Response Scale (DRS) Scores | Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. | up to 7 weeks | 
| Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Baseline and endpoint (up to 7 weeks) | 
| Change From Baseline in Pulse Rate at Endpoint |  | Baseline and endpoint (up to 7 weeks) | 
| Change From Baseline in Systolic Blood Pressure at Endpoint |  | Baseline and endpoint (up to 7 weeks) | 
| Change From Baseline in Diastolic Blood Pressure at Endpoint |  | Baseline and endpoint (up to 7 weeks) | 
| Change From Baseline in Weight at Endpoint |  | Baseline and endpoint (up to 7 weeks) |