A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire58 sites in 1 country461 target enrollmentSeptember 2, 2008

ConditionsADHD

InterventionsSPD503-PM Placebo SPD503-AM

DrugsSPD503-AM SPD503-PM Placebo

Overview

Phase: Phase 3
Intervention: SPD503-PM
Conditions: ADHD
Sponsor: Shire
Enrollment: 461
Locations: 58
Primary Endpoint: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (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 purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Registry

clinicaltrials.gov

Start Date

September 2, 2008

End Date

December 10, 2009

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
•Aged 6-17 years with a sub-optimal
•Partial response to stimulants
•Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs

Exclusion Criteria

Not provided

Arms & Interventions

SPD503-PM

SPD503 (Guanfacine Extended Release)

Intervention: SPD503-PM

Placebo

Intervention: Placebo

SPD503-AM

SPD503 (Guanfacine Extended Release)

Intervention: SPD503-AM

Outcomes

Primary Outcomes

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

Time Frame: Baseline and weekly 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

Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF(Baseline and week 8)
Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)(Baseline and weekly up to 8 weeks)
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF(Baseline and weekly up to 8 weeks)
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)(Baseline and weekly up to 8 weeks)