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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151970

Enrollment

128

Registered

2005-09-09

Start date

2005-06-30

Completion date

2006-10-31

Last updated

2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

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.

Interventions

DRUGMethylphenidate Transdermal System

MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes

DRUGPlacebo

Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily

DRUGConcerta

CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
SKAMP deportment rating scale	Week 8

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026