Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Methylphenidate Transdermal System

Detailed Description

To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).

• Study Type: Interventional
• Enrollment (Actual): 163
• 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
    • Gainsville, 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:

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:

• The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
• Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
• Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
• Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
• Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
• Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
• There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria are met at Entry:

• Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
• Subject is taking any medication that is excluded.
• Female subject who is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Methylphenidate Transdermal System	Drug: Methylphenidate Transdermal System; One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months; Other Names: DAYTRANA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure		Baseline and 6 months
Diastolic Blood Pressure		Baseline and 6 months
Pulse Rate		Baseline and 6 months
Electrocardiogram Results (QTcF Interval)	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 6 months
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.	6 months
Weight		Baseline and 6 months
Dermal Reactions	Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months	The 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 6 months
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months	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) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.	Baseline and 6 months
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	6 months
Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.	Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	6 months
Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months	The Youth Quality of Life-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). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Noven Therapeutics
• Investigators: Principal Investigator: Robert L. Findling, M.D., University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• Findling RL, Katic A, Rubin R, Moon E, Civil R, Li Y. A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):365-75. doi: 10.1089/cap.2009.0122.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: July 12, 2007
• First Submitted That Met QC Criteria: July 13, 2007
• First Posted (Estimate): July 16, 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: SPD485-410

Plan for Individual participant data (IPD)

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