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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
175
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Meadowbrook Research, Inc.
Scottsdale, Arizona, United States
Psychiatric Centers at San Diego
San Marcos, California, United States
Score on ADHD Rating Scale at 4 weeks
Time frame: 30 days
Parent rating scale
Time frame: 30 days
Parent Global Assessment
Time frame: 30 days
Medication Satisfaction Survey
Time frame: 30 days
ADHD Impact Module
Time frame: 30 days
Clinical Global Impressions Scale
Time frame: 30 days
Adverse events, lab tests, dermal evaluations, ECGs
Time frame: 30 days
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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
...and 8 more locations