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Completed

NCT Number: NCT00997984

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)

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BC Women;s Hospital and Health Centre, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended-release Guanfacine Hydrochloride (SPD503)

Drug

dosed in AM

Other names: Intuniv

Placebo

Drug

dosed in the AM or PM

Extended-release Guanfacine Hydrochloride

Drug

Dosed in the PM

Other names: Intuniv

Primary outcomes

  1. 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

    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 outcomes

  1. Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

    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)

  2. Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF

    Time frame: up to 8 weeks

    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.

  3. Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF

    Time frame: up to 8 weeks

    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.

  8. 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

    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.

  9. Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

  10. Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

  11. Change From Baseline in Pulse Rate at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

  12. Change From Baseline in Oral Temperature at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

  13. Change From Baseline in Height at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

  14. Change From Baseline in Weight at Week 8 - LOCF

    Time frame: Baseline and up to 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2009
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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