Efficacy and Safety of SPD503 in Combination With Psychostimulants

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.

Intervention(s) in this Clinical Trial

• Drug: SPD503-AM
  • SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
• Drug: SPD503-PM
  • SPD503 (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: SPD503-AM
  • SPD503 (Guanfacine Extended Release)
• Experimental: SPD503-PM
  • SPD503 (Guanfacine Extended Release)
• Placebo Comparator: Placebo

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF
  • Time Frame: Baseline and week 8
    Safety Issue?: No
• Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF
  • Time Frame: Baseline and weekly up to 8 weeks
    Safety Issue?: No
• Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
  • Time Frame: Baseline and weekly up to 8 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 Investigator: Shire Pharmaceutical Development Industry

Overall Clinical Trial Officials and Contacts

Timothy Wilens Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 02, 2012

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