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

March 27, 2017 updated by: Noven Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: Baseline and 6 months
Baseline and 6 months
Diastolic Blood Pressure
Time Frame: Baseline and 6 months
Baseline and 6 months
Pulse Rate
Time Frame: Baseline and 6 months
Baseline and 6 months
Electrocardiogram Results (QTcF Interval)
Time Frame: Baseline and 6 months
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
Time Frame: 6 months
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
Time Frame: Baseline and 6 months
Baseline and 6 months
Dermal Reactions
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: 6 months
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.
Time Frame: 6 months
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
Time Frame: Baseline and 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noven Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert L. Findling, M.D., University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD485-410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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