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

ADHD Clinical Trial

Official title:

A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499863
• Other study ID #: SPD485-409
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2007
• Last updated: June 23, 2015
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2015
• Source: Noven Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• methylphenidate transdermal system
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
• Placebo
Placebo patch

Locations

Country	Name	City	State
United States	FutureSearch Trials	Austin	Texas
United States	Claghorn-Lesem Research, Ltd.	Bellaire	Texas
United States	Northwest Clinical Research Center	Bellvue	Washington
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	CRI Worldwide	Clementon	New Jersey
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Triangle Neuropsychiatry	Durham	North Carolina
United States	Mountain West Clinical Trials, LLC	Eagle	Idaho
United States	Oregon Center for Clinical Investigations, Inc.	Eugene	Oregon
United States	Dakota Clinic/Innovis health	Fargo	North Dakota
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Bay Area Research Institute	Lafayette	California
United States	Shire Clinical Research Site	Lexington	Kentucky
United States	Westex Clinical Investigations	Lubbock	Texas
United States	Shire Clinical Research Site	Media	Pennsylvania
United States	CNS Healthcare	Memphis	Tennessee
United States	Adolescent Health Center	Midlothian	Virginia
United States	Odyssey Research	Minot	North Dakota
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	OCCI, Inc	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Northwest Behavioral Research Ctr	Roswell	Georgia
United States	Cerebral Research, LLC	San Antonio	Texas
United States	Melmed Center	Scottsdale	Arizona
United States	Miami Research Associates	South Miami	Florida
United States	Clinical Neurophysiology Services, PC	Troy	Michigan
United States	Elite Clinical Trials Inc.	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Noven Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Spect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 7 weeks	Yes
Primary	Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint	The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (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 endpoint (up to 7 weeks)	No
Secondary	Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint	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).	Baseline and endpoint (up to 7 weeks)	No
Secondary	Improvement in Clinical Global Impressions-Improvement (CGI-I) Score	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.	up to 7 weeks	No
Secondary	Improvement in Parent Global Assessment (PGA) Score	Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.	up to 7 weeks	No
Secondary	Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint	The Youth Quality of Life Instrument-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).	Baseline and endpoint (up to 7 weeks)	No
Secondary	Dermal Response Scale (DRS) Scores	Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.	up to 7 weeks	Yes
Secondary	Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint	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 endpoint (up to 7 weeks)	Yes
Secondary	Change From Baseline in Pulse Rate at Endpoint		Baseline and endpoint (up to 7 weeks)	Yes
Secondary	Change From Baseline in Systolic Blood Pressure at Endpoint		Baseline and endpoint (up to 7 weeks)	Yes
Secondary	Change From Baseline in Diastolic Blood Pressure at Endpoint		Baseline and endpoint (up to 7 weeks)	Yes
Secondary	Change From Baseline in Weight at Endpoint		Baseline and endpoint (up to 7 weeks)	Yes

External Links

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•   (FDA-approved Label)