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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00997984
First received: October 19, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Drug: extended-release guanfacine hydrochloride (SPD503)
Drug: placebo
Drug: extended-release guanfacine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.


Secondary Outcome Measures:
  • Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
    The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.

  • 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 ] [ Designated as safety issue: No ]
    HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.

  • 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 ] [ Designated as safety issue: No ]
    The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.

  • 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 ] [ Designated as safety issue: No ]
    The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.

  • Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.

  • 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 ] [ Designated as safety issue: No ]
    The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.

  • Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Pulse Rate at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Oral Temperature at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Height at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Week 8 - LOCF [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 340
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended-release Guanfacine Hydrochloride (SPD503) AM Drug: extended-release guanfacine hydrochloride (SPD503)
dosed in AM
Other Name: Intuniv
Experimental: placebo Drug: placebo
dosed in the AM or PM
Experimental: SPD503 PM Drug: extended-release guanfacine hydrochloride
Dosed in the PM
Other Name: Intuniv

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997984

  Show 46 Study Locations
Sponsors and Collaborators
Shire
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00997984     History of Changes
Other Study ID Numbers: SPD503-314
Study First Received: October 19, 2009
Results First Received: September 16, 2011
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014