To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
Systolic Blood Pressure
Time frame: Baseline and 6 months
Diastolic Blood Pressure
Time frame: Baseline and 6 months
Pulse Rate
Time frame: Baseline and 6 months
Electrocardiogram Results (QTcF Interval)
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline and 6 months
Post Sleep Questionnaire (PSQ) Quality of Sleep
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Time frame: 6 months
Weight
Time frame: Baseline and 6 months
Dermal Reactions
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Time frame: 6 months
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
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Melmed Center
Scottsdale, Arizona, United States
Bay Area Research Institute
Lafayette, California, United States
Elite Clinical Trials Inc.
Wildomar, California, United States
Sarkis Clinical Trials
Gainsville, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Northwest Behavioral Research Ctr
Roswell, Georgia, United States
Mountain West Clinical Trials, LLC
Eagle, Idaho, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Shire Clinical Research Site
Lexington, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
...and 22 more locations
Time frame: Baseline and 6 months
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Time frame: Baseline and 6 months
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 6 months
Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 6 months
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Time frame: Baseline and 6 months