SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

Official Title: “A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder”

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Intervention(s) in this Clinical Trial

• Drug: SPD503 (Guanfacine hydrochloride)
  • Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Assessment of Clinical Global Impression-Severity of Illness (CGI-S)
  • Time Frame: up to 8 weeks
    Safety Issue?: No
• Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
  • Time Frame: up to 8 weeks
    Safety Issue?: No
• Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)
  • Time Frame: up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Pulse Rate at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy subjects with ADHD and oppositional symptoms
• ADHD-RS>=24
• CGI >=4
• T-score of Opp subscale CPRS-R:L >=65
• Normal ECG and BP
• >= 55 lbs

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 Investigator: Shire Pharmaceutical Development Industry

Overall Clinical Trial Officials and Contacts

Thomas Spencer, M.D. Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367835

Study ID Number: SPD503-307

ClinicalTrials.gov Identifier: NCT00367835

Health Authority: United States: Food and Drug Administration

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