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

To assess the efficacy and safety of efficacy of MTS compared to placebo

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: methylphenidate transdermal system; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Melmed Center
  • California
    • Lafayette, California, United States
      • Bay Area Research Institute
    • Wildomar, California, United States
      • Elite Clinical Trials Inc.
  • Florida
    • Gainesville, Florida, United States
      • Sarkis Clinical Trials
    • South Miami, Florida, United States
      • Miami Research Associates
  • Georgia
    • Roswell, Georgia, United States
      • Northwest Behavioral Research Ctr
  • Idaho
    • Eagle, Idaho, United States
      • Mountain West Clinical Trials, LLC
  • Kansas
    • Overland Park, Kansas, United States
      • Vince and Associates Clinical Research
  • Kentucky
    • Lexington, Kentucky, United States
      • Shire Clinical Research Site
    • Paducah, Kentucky, United States
      • Four Rivers Clinical Research, Inc.
  • Michigan
    • Rochester Hills, Michigan, United States
      • Rochester Center for Behavioral Medicine
    • Troy, Michigan, United States
      • Clinical Neurophysiology Services, PC
  • New Jersey
    • Clementon, New Jersey, United States
      • CRI Worldwide
  • North Carolina
    • Durham, North Carolina, United States
      • Triangle Neuropsychiatry
  • North Dakota
    • Fargo, North Dakota, United States
      • Dakota Clinic/Innovis Health
    • Minot, North Dakota, United States
      • Odyssey Research
  • Ohio
    • Cleveland, Ohio, United States
      • University Hospitals Case Medical Center
  • Oregon
    • Eugene, Oregon, United States
      • Oregon Center for Clinical Investigations, Inc.
    • Portland, Oregon, United States
      • OCCI, Inc
  • Pennsylvania
    • Media, Pennsylvania, United States
      • Shire Clinical Research Site
    • Philadelphia, Pennsylvania, United States
      • CRI Worldwide
  • Rhode Island
    • Providence, Rhode Island, United States
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States
      • CNS Healthcare
  • Texas
    • Austin, Texas, United States
      • FutureSearch Trials
    • Bellaire, Texas, United States
      • Claghorn-Lesem Research, Ltd.
    • Lubbock, Texas, United States
      • Westex Clinical Investigations
    • San Antonio, Texas, United States
      • Cerebral Research, LLC
  • Vermont
    • Burlington, Vermont, United States
      • Vermont Clinical Study Center
  • Virginia
    • Herndon, Virginia, United States
      • Neuroscience, Inc.
    • Midlothian, Virginia, United States
      • Adolescent Health Center
  • Washington
    • Bellvue, Washington, United States
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methylphenidate Transdermal System; dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear	Drug: methylphenidate transdermal system; dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear; Other Names: DAYTRANA
Placebo Comparator: 2; Daily application of matching MTS Placebo Patch	Drug: Placebo; Placebo patch; Other Names: Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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).	Baseline and endpoint (up to 7 weeks)
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.	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.	Baseline and endpoint (up to 7 weeks)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 7 weeks

Collaborators and Investigators

• Sponsor: Noven Therapeutics
• Investigators: Principal Investigator: Robert L Finding, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 11, 2007
• First Posted (Estimate): July 12, 2007

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: SPD485-409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No