Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
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
1 other identifier
interventional
217
1 country
32
Brief Summary
To assess the efficacy and safety of efficacy of MTS compared to placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2007
Shorter than P25 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
June 11, 2009
CompletedApril 26, 2017
March 1, 2017
10 months
July 10, 2007
April 24, 2009
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline and endpoint (up to 7 weeks)
Secondary Outcomes (10)
Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint
Baseline and endpoint (up to 7 weeks)
Improvement in Clinical Global Impressions-Improvement (CGI-I) Score
up to 7 weeks
Improvement in Parent Global Assessment (PGA) Score
up to 7 weeks
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint
Baseline and endpoint (up to 7 weeks)
Dermal Response Scale (DRS) Scores
up to 7 weeks
- +5 more secondary outcomes
Other Outcomes (1)
Post Sleep Questionnaire (PSQ) Quality of Sleep
up to 7 weeks
Study Arms (2)
Methylphenidate Transdermal System
EXPERIMENTALdose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
2
PLACEBO COMPARATORDaily application of matching MTS Placebo Patch
Interventions
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Clinical Neurophysiology Services, PC
Troy, Michigan, United States
CRI Worldwide
Clementon, New Jersey, United States
Triangle Neuropsychiatry
Durham, North Carolina, United States
Dakota Clinic/Innovis health
Fargo, North Dakota, United States
Odyssey Research
Minot, North Dakota, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, United States
OCCI, Inc
Portland, Oregon, United States
Shire Clinical Research Site
Media, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
CNS Healthcare
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn-Lesem Research, Ltd.
Bellaire, Texas, United States
Westex Clinical Investigations
Lubbock, Texas, United States
Cerebral Research, LLC
San Antonio, Texas, United States
Vermont Clinical Study Center
Burlington, Vermont, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Adolescent Health Center
Midlothian, Virginia, United States
Northwest Clinical Research Center
Friday Harbor, Washington, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Related Publications (1)
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.
PMID: 20625364RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amaury Sanchez, Sr. Manager, Regulatory Affairs
- Organization
- Noven Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Finding, MD
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 12, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 26, 2017
Results First Posted
June 11, 2009
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share