Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
Information source: Noven Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: Methylphenidate Transdermal System (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Noven Therapeutics
Summary
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.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Score on ADHD Rating Scale at 4 weeks
Secondary outcome: Parent rating scaleParent Global Assessment Medication Satisfaction Survey ADHD Impact Module Clinical Global Impressions Scale Adverse events, lab tests, dermal evaluations, ECGs
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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
Additional Information
Starting date: June 2005
Last updated: July 8, 2015
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