Official Title: “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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

Not required

Intervention(s) in this Clinical Trial

• Drug: Guanfacine Hydrochloride Extended Release
  • Guanfacine Extended Release-AM Optimized 1-4mg
• Drug: Guanfacine Hydrochloride Extended Release
  • Guanfacine Extended Release-PM Optimized 1-4mg
• Drug: Placebo
  • Placebo matched to Guanfacine Hydrochloride Extended Release

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Guanfacine Extended Release-AM
• Experimental: B
  • Guanfacine Extended Release-PM
• Placebo Comparator: C
  • Placebo

Primary Measures

• Clinician-administered ADHD rating scale (ADHD-RS-IV)
  • Time Frame: 10 weeks
    Safety Issue?: No

Secondary Measures

• CGI of Severity and Improvement (CGI-S and CGI-I),CGI-P, PGA, Wil-Hammer Before School Functioning Scale, Oppositional Subscale of CPRS-R:L, PSQ
  • Time Frame: 10 Weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

Timothy Wilens Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734578

Study ID Number: SPD503-313

ClinicalTrials.gov Identifier: NCT00734578

Health Authority: United States: Food and Drug Administration