Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
- Registration Number
- NCT00499863
- Lead Sponsor
- Noven Therapeutics
- Brief Summary
To assess the efficacy and safety of efficacy of MTS compared to placebo
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
- Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- Subject is a male or female aged 13 17 years.
- Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
- Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
- Subject is overweight.
- Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has Conduct Disorder.
- Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
- Subject has a history of alcohol or other substance abuse or dependence.
- Subject has taken an investigational drug within 30 days prior to screening.
- Subject has any abnormal thyroid function.
- Subject has any clinically significant laboratory abnormalities.
- Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary.
- The female subject is pregnant or lactating.
- Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis).
- Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
- Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylphenidate Transdermal System methylphenidate transdermal system dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear 2 Placebo Daily application of matching MTS Placebo Patch
- Primary Outcome Measures
Name Time Method Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint baseline and endpoint (up to 7 weeks) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint Baseline and endpoint (up to 7 weeks) 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).
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score up to 7 weeks 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.
Improvement in Parent Global Assessment (PGA) Score up to 7 weeks 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.
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint Baseline and endpoint (up to 7 weeks) 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).
Dermal Response Scale (DRS) Scores up to 7 weeks 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.
Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint Baseline and endpoint (up to 7 weeks) 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.
Change From Baseline in Pulse Rate at Endpoint Baseline and endpoint (up to 7 weeks) Change From Baseline in Systolic Blood Pressure at Endpoint Baseline and endpoint (up to 7 weeks) Change From Baseline in Diastolic Blood Pressure at Endpoint Baseline and endpoint (up to 7 weeks) Change From Baseline in Weight at Endpoint Baseline and endpoint (up to 7 weeks)
Trial Locations
- Locations (30)
Miami Research Associates
🇺🇸South Miami, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Mountain West Clinical Trials, LLC
🇺🇸Eagle, Idaho, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Eugene, Oregon, United States
Vermont Clinical Study Center
🇺🇸Burlington, Vermont, United States
OCCI, Inc
🇺🇸Portland, Oregon, United States
Shire Clinical Research Site
🇺🇸Media, Pennsylvania, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Northwest Clinical Research Center
🇺🇸Bellvue, Washington, United States
Melmed Center
🇺🇸Scottsdale, Arizona, United States
Bay Area Research Institute
🇺🇸Lafayette, California, United States
Elite Clinical Trials Inc.
🇺🇸Wildomar, California, United States
Northwest Behavioral Research Ctr
🇺🇸Roswell, Georgia, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Neurophysiology Services, PC
🇺🇸Troy, Michigan, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Triangle Neuropsychiatry
🇺🇸Durham, North Carolina, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
Cerebral Research, LLC
🇺🇸San Antonio, Texas, United States
Westex Clinical Investigations
🇺🇸Lubbock, Texas, United States
NeuroScience, Inc.
🇺🇸Herndon, Virginia, United States
Adolescent Health Center
🇺🇸Midlothian, Virginia, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Dakota Clinic/Innovis health
🇺🇸Fargo, North Dakota, United States
Odyssey Research
🇺🇸Minot, North Dakota, United States
Claghorn-Lesem Research, Ltd.
🇺🇸Bellaire, Texas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States