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

Noven Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Methylphenidate Transdermal System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151983

SPD485-305

Details and patient eligibility

About

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.

Full description

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.

Enrollment

175 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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