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

Phase 2CompletedNCT00151970

Noven Therapeutics128 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

128

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate Transdermal SystemDRUG

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

PlaceboDRUG

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

ConcertaDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

SKAMP deportment rating scale

Time frame: Week 8

Secondary Outcomes

PERMP age-adjusted math test

Time frame: Week 8

Clinician-rated ADHD-RS-IV

Time frame: Week 8

CGI-I

Time frame: Week 8

Parent Global Assessment

Time frame: Week 8

Connors' Parent Rating Scale

Time frame: Week 8

ADHD Impact Module-Children

Time frame: Week 8

SKAMP-total and inattention subscales

Time frame: Week 8

Data from ClinicalTrials.gov

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