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 |
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.
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.
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
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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