A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder

Shire43 sites in 2 countries340 target enrollmentNovember 17, 2009

ConditionsAttention-Deficit/Hyperactivity Disorder

Interventionsextended-release guanfacine hydrochloride (SPD503)placebo extended-release guanfacine hydrochloride

Drugsextended-release guanfacine hydrochloride (SPD503)placebo extended-release guanfacine hydrochloride

Overview

Phase: Phase 3
Intervention: extended-release guanfacine hydrochloride (SPD503)
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Shire
Enrollment: 340
Locations: 43
Primary Endpoint: Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.

Registry

clinicaltrials.gov

Start Date

November 17, 2009

End Date

October 9, 2010

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•6-12 years old
•ADHD diagnosis
•ADHD-RS-IV minimum score of 28
•CGI-S score \> or = 4

Exclusion Criteria

•Current, controlled or uncontrolled, comorbid psychiatric diagnosis
•Condition or illness which represent inappropriate risk to subject
•Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension
•Use of prohibited medication that have CNS effects or affect cognitive performance
•History of alcohol or substance abuse within 6 months
•Current use of medication that affect BP or heart rate
•Significantly overweight
•Weight of less than 55 lbs
•Known allergy to SPD503
•Abnormal urine drug and alcohol screen

Arms & Interventions

Extended-release Guanfacine Hydrochloride (SPD503) AM

Intervention: extended-release guanfacine hydrochloride (SPD503)

placebo

Intervention: placebo

SPD503 PM

Intervention: extended-release guanfacine hydrochloride

Outcomes

Primary Outcomes

Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)

Time Frame: Baseline and up to 8 weeks

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.

Secondary Outcomes

Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF(Baseline and up to 8 weeks)
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF(up to 8 weeks)
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Pulse Rate at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Height at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Weight at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF(Baseline and up to 8 weeks)
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF(Baseline and up to 8 weeks)
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF(up to 8 weeks)
Change From Baseline in Oral Temperature at Week 8 - LOCF(Baseline and up to 8 weeks)