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...
Date First Received: September 7, 2005
Last Updated: November 2, 2007
Verified by: Shire Pharmaceutical Development, November 2007
Clinical Trial Phase: Phase 3 | Start Date: June 2005
Overall Status: Completed
Estimated Enrollment: 175
Brief Summary
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.”
Condition Keyword(s):
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
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Score on ADHD Rating Scale at 4 weeks
Secondary:
- Parent rating scale
- Parent Global Assessment
- Medication Satisfaction Survey
- ADHD Impact Module
- Clinical Global Impressions Scale
- Adverse events, lab tests, dermal evaluations, ECGs
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Shire Pharmaceutical Development
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
ADHD Clinic of San Antonio
San Antonio Texas United States
Claghorn-Lesem Research Clinic
Bellaire Texas United States
Monarch Medical Research
Norfolk Virginia United States
NeuroScience, Inc.
Herndon Virginia United States
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151983
Study ID Number: SPD485-305
ClinicalTrials.gov Identifier: NCT00151983
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
