Clinical trial NCT00151970: Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
Official title: A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Noven Pharmaceuticals, Inc.
First posted: 2005-09-09
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Detailed description: Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Eligibility criteria: Inclusion Criteria:

* Subjects have primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
* Subject has an IQ score of \>_ 80
* Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

* Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
* Subject is taking Strattera(r)
* Subject has a recent history of suspected substance abuse or dependence disorder

Primary outcomes:
measure: SKAMP deportment rating scale
timeFrame: Week 8
Secondary outcomes:
measure: PERMP age-adjusted math test
timeFrame: Week 8
measure: Clinician-rated ADHD-RS-IV
timeFrame: Week 8
measure: CGI-I
timeFrame: Week 8
measure: Parent Global Assessment
timeFrame: Week 8
measure: Connors' Parent Rating Scale
timeFrame: Week 8
measure: ADHD Impact Module-Children
timeFrame: Week 8
measure: SKAMP-total and inattention subscales
timeFrame: Week 8
Other outcomes:
Locations:
Study officials:
References:
citation: Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.
citation: Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.
citation: Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.