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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:6 - 12
Updated:4/21/2016
Start Date:June 2005
End Date:July 2006

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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.

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.

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
We found this trial at
18
sites
1000 Alpine
Boulder, Colorado 80304
303-443-7229
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Boulder, CO
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Bellaire, Texas 77401
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Bellaire, TX
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Chapel Hill, North Carolina
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Chapel Hill, NC
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Herndon, Virginia 20170
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Herndon, VA
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Kalamazoo, Michigan
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Kalamazoo, MI
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Libertyville, Illinois 60048
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Libertyville, IL
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Miami, Florida
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Miami, FL
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Norfolk, Virginia
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Norfolk, VA
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Owensboro, Kentucky 42301
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Owensboro, KY
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Portland, OR
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San Antonio, Texas 78247
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San Antonio, TX
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San Marcos, California
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San Marcos, CA
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Scottsdale, Arizona
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Scottsdale, AZ
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Toms River, New Jersey 08755
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Toms River, NJ
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