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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SPD503 (1 mg)
SPD503 (2 mg)
SPD503 (3 mg)
SPD503 (4 mg)
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    SPD503 (Guanfacine HCl) (1 mg)

    SPD503 (2 mg)

    SPD503 (3 mg)

    SPD503 (4 mg)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 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 Outcome Measures

    Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 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.
    Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
    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.
    Number of Participants With Improvement in Parent Global Assessment (PGA)
    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.
    Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 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.

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    May 29, 2021
    Sponsor
    Shire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00150618
    Brief Title
    Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
    Official 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 30, 2004 (Actual)
    Primary Completion Date
    October 7, 2004 (Actual)
    Study Completion Date
    October 7, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shire

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    324 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SPD503 (Guanfacine HCl) (1 mg)
    Arm Type
    Experimental
    Arm Title
    SPD503 (2 mg)
    Arm Type
    Experimental
    Arm Title
    SPD503 (3 mg)
    Arm Type
    Experimental
    Arm Title
    SPD503 (4 mg)
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    SPD503 (1 mg)
    Other Intervention Name(s)
    Guanfacine hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    SPD503 (2 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    SPD503 (3 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    SPD503 (4 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks
    Description
    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.
    Time Frame
    Baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks
    Description
    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.
    Time Frame
    Baseline and 6 weeks
    Title
    Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
    Description
    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.
    Time Frame
    6 weeks
    Title
    Number of Participants With Improvement in Parent Global Assessment (PGA)
    Description
    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.
    Time Frame
    6 weeks
    Title
    Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks
    Description
    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.
    Time Frame
    Baseline and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19106767
    Citation
    Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.
    Results Reference
    result
    Links:
    URL
    http://www.fda.gov/opacom/7alerts.html
    Description
    FDA recall information
    URL
    http://www.intuniv.com/documents/INTUNIV_Full_Prescribing_Information.pdf
    Description
    FDA-approved label

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

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