- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151983
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
July 8, 2015 updated by: Noven Therapeutics
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
175
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States
- Meadowbrook Research, Inc.
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California
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San Marcos, California, United States
- Psychiatric Centers at San Diego
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Colorado
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Boulder, Colorado, United States
- Alpine Clinical Research Center
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Florida
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Miami, Florida, United States
- Miami Research Associates, Inc.
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Illinois
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Libertyville, Illinois, United States
- Capstone Clinical Research
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Kentucky
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Owensboro, Kentucky, United States
- Pedia Research, LLC
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Michigan
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Kalamazoo, Michigan, United States
- ProMed Pediatrics
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New Jersey
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Toms River, New Jersey, United States
- Children's Specialized Hospital
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North Carolina
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Chapel Hill, North Carolina, United States
- North Carolina Neuropsychiatry PA
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Ohio
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Columbus, Ohio, United States
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States
- IPS Research Company
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Oregon
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Portland, Oregon, United States
- Oregon Center for Clinical Investigations (OCCI, Inc.)
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- CNS Research Institute
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Pittsburgh, Pennsylvania, United States
- Western Psychiatric Institute & Clinic
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Texas
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Bellaire, Texas, United States
- Claghorn-Lesem Research Clinic
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San Antonio, Texas, United States
- ADHD Clinic of San Antonio
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Virginia
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Herndon, Virginia, United States
- Neuroscience, Inc.
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Norfolk, Virginia, United States
- Monarch Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Methylphenidate Transdermal System
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
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To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Names:
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Placebo Comparator: Placebo patch
Placebo patch applied daily for 8 weeks
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To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on ADHD Rating Scale at 4 weeks
Time Frame: 30 days
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30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Parent rating scale
Time Frame: 30 days
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30 days
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Parent Global Assessment
Time Frame: 30 days
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30 days
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Medication Satisfaction Survey
Time Frame: 30 days
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30 days
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ADHD Impact Module
Time Frame: 30 days
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30 days
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Clinical Global Impressions Scale
Time Frame: 30 days
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30 days
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Adverse events, lab tests, dermal evaluations, ECGs
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Estimate)
July 9, 2015
Last Update Submitted That Met QC Criteria
July 8, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- SPD485-305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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