Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

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)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: Methylphenidate Transdermal System; Drug: Placebo; Drug: Concerta

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methylphenidate Transdermal System; The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.	Drug: Methylphenidate Transdermal System; MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes; Other Names: MTS
Placebo Comparator: Placebo; The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.	Drug: Placebo; Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily; Other Names: Sham Treatment
Active Comparator: Concerta; CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily	Drug: Concerta; CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily; Other Names: Methylphenidate HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SKAMP deportment rating scale	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
PERMP age-adjusted math test	Week 8
Clinician-rated ADHD-RS-IV	Week 8
CGI-I	Week 8
Parent Global Assessment	Week 8
Connors' Parent Rating Scale	Week 8
ADHD Impact Module-Children	Week 8
SKAMP-total and inattention subscales	Week 8

Collaborators and Investigators

• Sponsor: Noven Therapeutics
• Collaborators: Noven Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• FDA Recall Information

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: SPD485-304