Conditions: ADHD
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 163
Healthy volunteers: no

Brief summary:
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Detailed description:
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).

Arms:
arm 1: Methylphenidate Transdermal System

Interventions: intervention 1: Methylphenidate Transdermal System
Intervention descriptions: intervention 1: One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

Protocol document: