A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder.
OBJECTIVE
The aim of this study was to evaluate the tolerability and effectiveness of the methylphenidate transdermal system (MTS) over 6 months in adolescents with attention-deficit/hyperactivity disorder (ADHD).


METHODS
This was an industry-sponsored, 30-center, open-label study of subjects aged 13-17 years with ADHD. Subjects were dose-optimized with MTS (10-30 mg/9 hours) over 5 weeks and then dose-maintained for up to 5 months. Tolerability evaluations included treatment-emergent adverse events (TEAEs) and dermal responses. Effectiveness was assessed with the ADHD-Rating Scale-IV (ADHD-RS-IV).


RESULTS
A total of 162 subjects received MTS treatment. The majority of TEAEs (>99%) were mild or moderate in intensity, and the most frequently reported TEAE was decreased appetite (15.4%). Thirteen subjects discontinued the study due to TEAEs. The majority (93.6%) of dermatologic reactions indicated mild erythema. There was significant improvement in mean ADHD-RS-IV total scores from study entry to end point (p<0.001).


CONCLUSIONS
Slightly more than half (54.0%) of subjects completed this 6-month, open-label extension study of MTS; the primary reason for discontinuation was withdrawn consent (36.0%). Reported TEAEs and skin tolerability findings were similar to those observed with MTS use in children and adolescents. MTS treatment resulted in a decrease in ADHD symptoms as rated by clinicians.
Findling
Robert L
RL
University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio 44106, USA. robert.findling@UHhospitals.org
Katic
Alain
A
Rubin
Richard
R
Moon
Eliot
E
Civil
Richard
R
Li
Yunfeng
Y
D000279:Administration, Cutaneous; D000293:Adolescent; D001066:Appetite; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects* / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D008774:Methylphenidate