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

NCT00501293 | Completed Phase 3 Results

• 1 other identifier: SPD485-410
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

ADHD

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months

  Baseline and 6 months

• Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months

  Baseline and 6 months

• Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

  6 months

• Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.

  6 months

• Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months

  Baseline and 6 months

Study Arms (1)

1

EXPERIMENTAL

Methylphenidate Transdermal System

Drug: Methylphenidate Transdermal System

Interventions

Methylphenidate Transdermal System DRUG

One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

Also known as: DAYTRANA

1

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 is taking any medication that is excluded.
• Female subject who is pregnant or lactating.

Sponsors & Collaborators

• Noven Therapeutics: lead

Study Sites (32)

Melmed Center

Scottsdale, Arizona, United States

Location

Bay Area Research Institute

Lafayette, California, United States

Location

Elite Clinical Trials Inc.

Wildomar, California, United States

Location

Sarkis Clinical Trials

Gainsville, Florida, United States

Location

Miami Research Associates

South Miami, Florida, United States

Location

Northwest Behavioral Research Ctr

Roswell, Georgia, United States

Location

Mountain West Clinical Trials, LLC

Eagle, Idaho, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Location

Shire Clinical Research Site

Lexington, Kentucky, United States

Location

Four Rivers Clinical Research, Inc.

Paducah, Kentucky, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Location

Clinical Neurophysiology Services, PC

Troy, Michigan, United States

Location

CRI Worldwide

Clementon, New Jersey, United States

Location

Triangle Neuropsychiatry

Durham, North Carolina, United States

Location

Dakota Clinic/Innovis Health

Fargo, North Dakota, United States

Location

Odyssey Research

Minot, North Dakota, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Location

Oregon center for Clinical Investigations, Inc.

Eugene, Oregon, United States

Location

OCCI, Inc

Portland, Oregon, United States

Location

Shire Clinical Research Site

Media, Pennsylvania, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, United States

Location

Rhode Island Hospital

Providence, Rhode Island, United States

Location

CNS Healthcare

Memphis, Tennessee, United States

Location

FutureSearch Trials

Austin, Texas, United States

Location

Claghorn-Lesem Research, Ltd.

Bellaire, Texas, United States

Location

Westex Clinical Investigations

Lubbock, Texas, United States

Location

Cerebral Research, LLC

San Antonio, Texas, United States

Location

Vermont Clinical Study Center

Burlington, Vermont, United States

Location

NeuroScience, Inc.

Herndon, Virginia, United States

Location

Adolescent Health Center

Midlothian, Virginia, United States

Location

Northwest Clinical Research Center

Friday Harbor, Washington, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 20973707 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Timothy Whitaker, MD
• Organization: Shire Pharmaceutical

twhitaker@shire.com

Study Officials

• Robert L. Findling, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 26, 2017
• Results First Posted: January 15, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)