To assess the efficacy and safety of efficacy of MTS compared to placebo
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
Placebo patch
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (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.
Time frame: baseline and endpoint (up to 7 weeks)
Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
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).
Time frame: Baseline and endpoint (up to 7 weeks)
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: up to 7 weeks
Improvement in Parent Global Assessment (PGA) Score
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: up to 7 weeks
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
The Youth Quality of Life Instrument-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).
Time frame: Baseline and endpoint (up to 7 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Gainesville, 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
Dermal Response Scale (DRS) Scores
Mean dermal reaction scores 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: up to 7 weeks
Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint
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 endpoint (up to 7 weeks)
Change From Baseline in Pulse Rate at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Systolic Blood Pressure at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Diastolic Blood Pressure at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)
Change From Baseline in Weight at Endpoint
Time frame: Baseline and endpoint (up to 7 weeks)