Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Registration Number
- NCT00151983
- Lead Sponsor
- Noven Therapeutics
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo patch Methylphenidate Transdermal System Placebo patch applied daily for 8 weeks Methylphenidate Transdermal System Methylphenidate Transdermal System Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
- Primary Outcome Measures
Name Time Method Score on ADHD Rating Scale at 4 weeks 30 days
- Secondary Outcome Measures
Name Time Method Parent rating scale 30 days Medication Satisfaction Survey 30 days Parent Global Assessment 30 days ADHD Impact Module 30 days Clinical Global Impressions Scale 30 days Adverse events, lab tests, dermal evaluations, ECGs 30 days
Trial Locations
- Locations (18)
ProMed Pediatrics
🇺🇸Kalamazoo, Michigan, United States
CNS Research Institute
🇺🇸Philadelphia, Pennsylvania, United States
Western Psychiatric Institute & Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Psychiatric Centers at San Diego
🇺🇸San Marcos, California, United States
Meadowbrook Research, Inc.
🇺🇸Scottsdale, Arizona, United States
Miami Research Associates, Inc.
🇺🇸Miami, Florida, United States
ADHD Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Children's Specialized Hospital
🇺🇸Toms River, New Jersey, United States
Oregon Center for Clinical Investigations (OCCI, Inc.)
🇺🇸Portland, Oregon, 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
Claghorn-Lesem Research Clinic
🇺🇸Bellaire, Texas, United States
Monarch Medical Research
🇺🇸Norfolk, Virginia, United States
NeuroScience, Inc.
🇺🇸Herndon, Virginia, United States