Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
NCT ID: NCT00151983
Last Updated: 2015-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
175 participants
INTERVENTIONAL
2005-06-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Methylphenidate Transdermal System
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Placebo patch
Placebo patch applied daily for 8 weeks
Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Interventions
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Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
12 Years
ALL
No
Sponsors
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Noven Pharmaceuticals, Inc.
INDUSTRY
Noven Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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SPD485-305
Identifier Type: -
Identifier Source: org_study_id
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