Clinical trial NCT00151983: Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Noven Pharmaceuticals, Inc.
First posted: 2005-09-09
Enrollment: 175
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Score on ADHD Rating Scale at 4 weeks
timeFrame: 30 days
Secondary outcomes:
measure: Parent rating scale
timeFrame: 30 days
measure: Parent Global Assessment
timeFrame: 30 days
measure: Medication Satisfaction Survey
timeFrame: 30 days
measure: ADHD Impact Module
timeFrame: 30 days
measure: Clinical Global Impressions Scale
timeFrame: 30 days
measure: Adverse events, lab tests, dermal evaluations, ECGs
timeFrame: 30 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Meadowbrook Research, Inc.
state: Arizona
city: San Marcos
country: United States
facility: Psychiatric Centers at San Diego
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Kalamazoo
country: United States
facility: ProMed Pediatrics
state: Michigan
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Chapel Hill
country: United States
facility: North Carolina Neuropsychiatry PA
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations (OCCI, Inc.)
state: Oregon
city: Philadelphia
country: United States
facility: CNS Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute & Clinic
state: Pennsylvania
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: San Antonio
country: United States
facility: ADHD Clinic of San Antonio
state: Texas
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Monarch Medical Research
state: Virginia
Study officials:
References:
citation: Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39.
citation: 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. doi: 10.1185/03007990903437412.