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
Miami, Florida
1322
mi
from
Miami, FL
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
430
mi
from
Boulder, CO
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Bellaire, Texas 77401
572
mi
from
Bellaire, TX
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Chapel Hill, North Carolina
1043
mi
from
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...
810
mi
from
Columbus, OH
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Herndon, Virginia 20170
1108
mi
from
Herndon, VA
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Kalamazoo, Michigan
718
mi
from
Kalamazoo, MI
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Libertyville, Illinois 60048
608
mi
from
Libertyville, IL
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Norfolk, Virginia
1182
mi
from
Norfolk, VA
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Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
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Owensboro, Kentucky 42301
581
mi
from
Owensboro, KY
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Philadelphia, Pennsylvania
1225
mi
from
Philadelphia, PA
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Pittsburgh, Pennsylvania 15213
974
mi
from
Pittsburgh, PA
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1385
mi
from
Portland, OR
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San Antonio, Texas 78247
565
mi
from
San Antonio, TX
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San Marcos, California
1131
mi
from
San Marcos, CA
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Scottsdale, Arizona
843
mi
from
Scottsdale, AZ
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Toms River, New Jersey 08755
1276
mi
from
Toms River, NJ
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