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

NCT ID: NCT00499863

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-05-31

Brief Summary

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

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylphenidate Transdermal System

dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear

Group Type: EXPERIMENTAL

methylphenidate transdermal system

Intervention Type: DRUG

dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear

2

Daily application of matching MTS Placebo Patch

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo patch

Interventions

methylphenidate transdermal system

dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear

Intervention Type: DRUG

Placebo

Placebo patch

Intervention Type: DRUG

Other Intervention Names

DAYTRANA; Sham treatment

Eligibility Criteria

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.

• 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 Finding, MD

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

Gainesville, 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, 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.

Reference Type: RESULT

PMID: 20625364 (View on PubMed)

Other Identifiers

SPD485-409

Identifier Type: -

Identifier Source: org_study_id