Clinical trial NCT00499863: Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Official title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of MTS in Adolescents Aged 13-17 Years With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 217
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject must meet criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
2. Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
3. 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.
4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
5. Subject is a male or female aged 13 17 years.
6. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Subject is overweight.
4. 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.
5. Subject has Conduct Disorder.
6. Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
7. Subject has a history of alcohol or other substance abuse or dependence.
8. Subject has taken an investigational drug within 30 days prior to screening.
9. Subject has any abnormal thyroid function.
10. Subject has any clinically significant laboratory abnormalities.
11. 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.
12. The female subject is pregnant or lactating.
13. 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).
14. 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.
15. Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.

Primary outcomes:
measure: Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint
timeFrame: baseline and endpoint (up to 7 weeks)
Secondary outcomes:
measure: Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
timeFrame: up to 7 weeks
measure: Improvement in Parent Global Assessment (PGA) Score
timeFrame: up to 7 weeks
measure: Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Dermal Response Scale (DRS) Scores
timeFrame: up to 7 weeks
measure: Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Change From Baseline in Pulse Rate at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Change From Baseline in Systolic Blood Pressure at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Change From Baseline in Diastolic Blood Pressure at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
measure: Change From Baseline in Weight at Endpoint
timeFrame: Baseline and endpoint (up to 7 weeks)
Other outcomes:
measure: Post Sleep Questionnaire (PSQ) Quality of Sleep
timeFrame: up to 7 weeks
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Lafayette
country: United States
facility: Bay Area Research Institute
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials Inc.
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Roswell
country: United States
facility: Northwest Behavioral Research Ctr
state: Georgia
city: Eagle
country: United States
facility: Mountain West Clinical Trials, LLC
state: Idaho
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Lexington
country: United States
facility: Shire Clinical Research Site
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Troy
country: United States
facility: Clinical Neurophysiology Services, PC
state: Michigan
city: Clementon
country: United States
facility: CRI Worldwide
state: New Jersey
city: Durham
country: United States
facility: Triangle Neuropsychiatry
state: North Carolina
city: Fargo
country: United States
facility: Dakota Clinic/Innovis health
state: North Dakota
city: Minot
country: United States
facility: Odyssey Research
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Eugene
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Portland
country: United States
facility: OCCI, Inc
state: Oregon
city: Media
country: United States
facility: Shire Clinical Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigations
state: Texas
city: San Antonio
country: United States
facility: Cerebral Research, LLC
state: Texas
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Midlothian
country: United States
facility: Adolescent Health Center
state: Virginia
city: Bellvue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Robert L Finding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findling RL, Turnbow J, Burnside J, Melmed R, Civil R, Li Y. A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents. CNS Spectr. 2010 Jul;15(7):419-30. doi: 10.1017/s1092852900000353.