Official Title: “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”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2010

Intervention(s) in this Clinical Trial

• Drug: extended-release guanfacine hydrochloride
  • dosed in AM
• Drug: placebo
  • dosed in the AM or PM
• Drug: extended-release guanfacine hydrochloride
  • Dosed in the PM

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SPD503 AM
• Experimental: placebo
• Experimental: SPD503 PM

Primary Measures

• Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV)
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• Clinical Global Impressions - Severity of Illness Scale (CGI-S)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Clinical Global Impressions - Improvement Scale (CGI-I)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Pediatric Daytime Sleepiness Scale (PDSS)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Health Utilities Index (HUI)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Conners' Parent Rating Scale - Revised: Short form (CPRS-R:S)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Bedtime Resistance subscale of Child's Sleep Habits Questionnaire (CSHQ)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Post-Sleep Questionnaire (PSQ)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
  • Time Frame: 9 weeks
    Safety Issue?: Yes
• Treatment Emergent Adverse (TEAEs) and Vital signs
  • Time Frame: 9 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00997984

Study ID Number: SPD503-314

ClinicalTrials.gov Identifier: NCT00997984

Health Authority: United States: Food and Drug Administration