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

NCT ID: NCT00501293

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-02-28

Brief Summary

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

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).

Conditions

ADHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Methylphenidate Transdermal System

Group Type: EXPERIMENTAL

Methylphenidate Transdermal System

Intervention Type: DRUG

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

Interventions

Methylphenidate Transdermal System

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

Intervention Type: DRUG

Other Intervention Names

DAYTRANA

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noven Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. Findling, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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

Gainsville, 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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20973707 (View on PubMed)

Other Identifiers

SPD485-410

Identifier Type: -

Identifier Source: org_study_id