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

Official Title: “A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)”

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Intervention(s) in this Clinical Trial

• Drug: SPD503 (1 mg)
• Drug: SPD503 (2 mg)
• Drug: SPD503 (3 mg)
• Drug: SPD503 (4 mg)
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SPD503 (Guanfacine HCl) (1 mg)
• Experimental: SPD503 (2 mg)
• Experimental: SPD503 (3 mg)
• Experimental: SPD503 (4 mg)
• Placebo Comparator: Placebo

Primary Measures

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) 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)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Number of Participants With Improvement in Parent Global Assessment (PGA)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

• Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
• Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
• Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
• Subject is pregnant or lactating

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 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150618

Study ID Number: SPD503-304

ClinicalTrials.gov Identifier: NCT00150618

Health Authority: United States: Food and Drug Administration

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