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Completed

NCT Number: NCT00734578

Efficacy and Safety of SPD503 in Combination With Psychostimulants

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harmonex Neuroscience Research, Dothan, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
  • Aged 6-17 years with a sub-optimal
  • Partial response to stimulants
  • Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs

Treatment and study plan

SPD503-AM

Drug

SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg

Other names: Intuniv

SPD503-PM

Drug

SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg

Other names: Intuniv

Placebo

Drug

Placebo matched to Guanfacine Hydrochloride Extended Release

Primary outcomes

  1. Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)

    Time frame: Baseline and weekly 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. Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF

    Time frame: Baseline and weekly 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 is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

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

    Time frame: Baseline and weekly 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)

  3. Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)

    Time frame: Baseline and weekly up to 8 weeks

    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.

  4. Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)

    Time frame: Baseline and weekly up to 8 weeks

    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.

  5. Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF

    Time frame: Baseline and week 8

    Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

  6. Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF

    Time frame: Baseline and weekly up to 8 weeks

    The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.

  7. Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF

    Time frame: Baseline and weekly up to 8 weeks

    This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.

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

    Time frame: Baseline and weekly 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2008
Registry last updated
Jun 14, 2021

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

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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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