Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17

Phase 3CompletedNCT00152009

Shire345 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

345

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

SPD503 (Guanfacine hydrochloride) (2 mg)DRUG

SPD503 (3 mg)DRUG

SPD503 (4 mg)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with a primary diagnosis of ADHD * Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Exclusion Criteria: * Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms * History of seizure during the last 2 years * Subject has any specific cardiac condition or family history of significant cardiac condition * Subject is pregnant or lactating

Outcomes

Primary Outcomes

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Time frame: Baseline and up to 5 weeks

Secondary Outcomes

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks

The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.

Time frame: Baseline and up to 5 weeks

Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks

The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.

Time frame: Baseline and up to 5 weeks

Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Time frame: up to 5 weeks

Data from ClinicalTrials.gov

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