Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
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.
1 other identifier
interventional
175
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJuly 9, 2015
July 1, 2015
1.1 years
September 7, 2005
July 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Score on ADHD Rating Scale at 4 weeks
30 days
Secondary Outcomes (6)
Parent rating scale
30 days
Parent Global Assessment
30 days
Medication Satisfaction Survey
30 days
ADHD Impact Module
30 days
Clinical Global Impressions Scale
30 days
- +1 more secondary outcomes
Study Arms (2)
Methylphenidate Transdermal System
ACTIVE COMPARATORMethylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Placebo patch
PLACEBO COMPARATORPlacebo patch applied daily for 8 weeks
Interventions
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noven Therapeuticslead
- Noven Pharmaceuticals, Inc.collaborator
Study Sites (18)
Meadowbrook Research, Inc.
Scottsdale, Arizona, United States
Psychiatric Centers at San Diego
San Marcos, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Miami Research Associates, Inc.
Miami, Florida, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
ProMed Pediatrics
Kalamazoo, Michigan, United States
Children's Specialized Hospital
Toms River, New Jersey, United States
North Carolina Neuropsychiatry PA
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations (OCCI, Inc.)
Portland, Oregon, United States
CNS Research Institute
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Monarch Medical Research
Norfolk, Virginia, United States
Related Publications (2)
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.
PMID: 20003260DERIVEDArnold 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.
PMID: 19916704DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
June 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
July 9, 2015
Record last verified: 2015-07