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

ADHD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501293
• Other study ID #: SPD485-410
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2007
• Last updated: June 23, 2015
• Start date: August 2007
• Est. completion date: February 2009

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Methylphenidate Transdermal System
One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

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	Gainsville	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, 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 Ad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure		Baseline and 6 months	Yes
Primary	Diastolic Blood Pressure		Baseline and 6 months	Yes
Primary	Pulse Rate		Baseline and 6 months	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Weight		Baseline and 6 months	Yes
Primary	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	Yes
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 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	No
Secondary	Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 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	No
Secondary	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	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	No
Secondary	Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.	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	No
Secondary	Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 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	No

External Links

•   FDA recall information
•   FDA-approved label