Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

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.

Intervention(s) in this Clinical Trial

• Drug: extended-release guanfacine hydrochloride (SPD503)
  • 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: Extended-release Guanfacine Hydrochloride (SPD503) AM
• Experimental: placebo
• Experimental: SPD503 PM

Primary Measures

• Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No

Secondary Measures

• Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
  • Time Frame: up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
  • Time Frame: up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: No
• Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Pulse Rate at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Oral Temperature at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Height at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 weeks
    Safety Issue?: Yes
• Change From Baseline in Weight at Week 8 - LOCF
  • Time Frame: Baseline and up to 8 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 Investigator: Shire Pharmaceutical Development Industry

Information obtained from ClinicalTrials.gov on February 02, 2012

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