Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Condition: ADHD
Intervention: methylphenidate transdermal system; Placebo
Intervention description: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear; Placebo patch
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of efficacy of MTS compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must meet criteria for a primary diagnosis of ADHD based on a detailed
             psychiatric evaluation.

          2. Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit
             2).

          3. 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.

          4. Subject has blood pressure measurements within the 95th percentile for age, gender,
             and height at Screening and Baseline.

          5. Subject is a male or female aged 13 17 years.

          6. 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:

          1. 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.

          2. 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.

          3. Subject is overweight.

          4. 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.

          5. Subject has Conduct Disorder.

          6. Subject has a positive urine drug or alcohol result at Screening (with the exception
             of subject's current stimulant therapy, if any).

          7. Subject has a history of alcohol or other substance abuse or dependence.

          8. Subject has taken an investigational drug within 30 days prior to screening.

          9. Subject has any abnormal thyroid function.

         10. Subject has any clinically significant laboratory abnormalities.

         11. 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.

         12. The female subject is pregnant or lactating.

         13. 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).

         14. 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.

         15. Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning,
             erythema) or scars or tattoos.