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

This study has been completed.

First Received on September 7, 2005. Last Updated on November 2, 2007 History of Changes

Sponsor:	Shire Development LLC
Collaborator:	Noven Therapeutics
Information provided by:	Shire Development LLC
ClinicalTrials.gov Identifier:	NCT00151983

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: 'd, I (threo)-methylphenidate, Methylphenidate Transdermal System	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:

Score on ADHD Rating Scale at 4 weeks

Secondary Outcome Measures:

Parent rating scale
Parent Global Assessment
Medication Satisfaction Survey
ADHD Impact Module
Clinical Global Impressions Scale
Adverse events, lab tests, dermal evaluations, ECGs

Estimated Enrollment:	175
Study Start Date:	June 2005
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151983

Locations

United States, Arizona
Meadowbrook Research, Inc.
Scottsdale, Arizona, United States
United States, California
Psychiatric Centers at San Diego
San Marcos, California, United States
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States
United States, Florida
Miami Research Associates, Inc.
Miami, Florida, United States
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States
United States, Kentucky
Pedia Research, LLC
Owensboro, Kentucky, United States
United States, Michigan
ProMed Pediatrics
Kalamazoo, Michigan, United States
United States, New Jersey
Children's Specialized Hospital
Toms River, New Jersey, United States
United States, North Carolina
North Carolina Neuropsychiatry PA
Chapel Hill, North Carolina, United States
United States, Ohio
Ohio State University
Columbus, Ohio, United States
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States
United States, Oregon
Oregon Center for Clinical Investigations (OCCI, Inc.)
Portland, Oregon, United States
United States, Pennsylvania
CNS Research Institute
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States
United States, Texas
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
United States, Virginia
NeuroScience, Inc.
Herndon, Virginia, United States
Monarch Medical Research
Norfolk, Virginia, United States

Sponsors and Collaborators

Shire Development LLC

Noven Therapeutics

More Information

No publications provided by Shire Development LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37.

ClinicalTrials.gov Identifier:	NCT00151983 History of Changes
Other Study ID Numbers:	SPD485-305
Study First Received:	September 7, 2005
Last Updated:	November 2, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012