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

Noven Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

ADHD

Treatments

Drug: methylphenidate transdermal system

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00499863

SPD485-409

Details and patient eligibility

About

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

Full description

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.

Enrollment

217 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.