Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17

Official Title: “A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)”

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Intervention(s) in this Clinical Trial

• Drug: SPD503 (Guanfacine HCl)
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SPD503 (Guanfacine HCl)
• Placebo Comparator: Placebo

Primary Measures

• Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No
• Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No
• Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No
• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No
• Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks
  • Time Frame: 6 weeks
    Safety Issue?: No
• Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: Yes
• Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
• Subject weighs > 55 lbs and is not morbidly overweight

Exclusion Criteria:

• Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
• Subject has a history of seizure disorder
• Subject has any specific cardiac condition or family history of significant cardiac condition
• Subject is pregnant, lactating or within six month post-partum

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150592

Study ID Number: SPD503-206

ClinicalTrials.gov Identifier: NCT00150592

Health Authority: United States: Food and Drug Administration

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