Clinical trial NCT00501293: Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 163
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Diastolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Pulse Rate
timeFrame: Baseline and 6 months
measure: Electrocardiogram Results (QTcF Interval)
timeFrame: Baseline and 6 months
measure: Post Sleep Questionnaire (PSQ) Quality of Sleep
timeFrame: 6 months
measure: Weight
timeFrame: Baseline and 6 months
measure: Dermal Reactions
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months
timeFrame: Baseline and 6 months
measure: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
timeFrame: 6 months
measure: Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.
timeFrame: 6 months
measure: Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Lafayette
country: United States
facility: Bay Area Research Institute
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials Inc.
state: California
city: Gainsville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Roswell
country: United States
facility: Northwest Behavioral Research Ctr
state: Georgia
city: Eagle
country: United States
facility: Mountain West Clinical Trials, LLC
state: Idaho
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Lexington
country: United States
facility: Shire Clinical Research Site
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Troy
country: United States
facility: Clinical Neurophysiology Services, PC
state: Michigan
city: Clementon
country: United States
facility: CRI Worldwide
state: New Jersey
city: Durham
country: United States
facility: Triangle Neuropsychiatry
state: North Carolina
city: Fargo
country: United States
facility: Dakota Clinic/Innovis Health
state: North Dakota
city: Minot
country: United States
facility: Odyssey Research
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Eugene
country: United States
facility: Oregon center for Clinical Investigations, Inc.
state: Oregon
city: Portland
country: United States
facility: OCCI, Inc
state: Oregon
city: Media
country: United States
facility: Shire Clinical Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigations
state: Texas
city: San Antonio
country: United States
facility: Cerebral Research, LLC
state: Texas
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Midlothian
country: United States
facility: Adolescent Health Center
state: Virginia
city: Bellvue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Robert L. Findling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.