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Completed

NCT Number: NCT00150618

Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

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Key information

Conditions

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with a primary diagnosis of ADHD
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion criteria

  • Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
  • Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
  • Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
  • Subject is pregnant or lactating

Treatment and study plan

SPD503 (1 mg)

Drug

Other names: Guanfacine hydrochloride

SPD503 (2 mg)

Drug

SPD503 (3 mg)

Drug

SPD503 (4 mg)

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks

    Time frame: Baseline and 6 weeks

    Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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. Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks

    Time frame: Baseline and 6 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.

  2. Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)

    Time frame: 6 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.

  3. Number of Participants With Improvement in Parent Global Assessment (PGA)

    Time frame: 6 weeks

    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.

  4. Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks

    Time frame: Baseline and 6 weeks

    The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Sep 8, 2005
Registry last updated
Jun 10, 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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