Back to resultsSafety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Methylphenidate + SPD503 (Guanfacine hydrochloride)
Amphetamine + SPD503
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
Inclusion Criteria: Subjects with a primary diagnosis of ADHD Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Exclusion Criteria: Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms History of seizure during the last 2 years Subject has any specific cardiac condition or family history of significant cardiac condition Subject is pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methylphenidate + SPD503
Amphetamine + SPD503
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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.
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total 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 on Parent Global Assessment (PGA) Scores
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. 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) Scores 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 for each. Increases in scores represent improved well-being in subjects as assessed by their parents.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151996
Brief Title
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants 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
August 16, 2004 (Actual)
Primary Completion Date
December 27, 2004 (Actual)
Study Completion Date
December 27, 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 assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate + SPD503
Arm Type
Experimental
Arm Title
Amphetamine + SPD503
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylphenidate + SPD503 (Guanfacine hydrochloride)
Intervention Type
Drug
Intervention Name(s)
Amphetamine + SPD503
Primary Outcome Measure Information:
Title
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total 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 on Parent Global Assessment (PGA) Scores
Description
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. 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) Scores 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 for each. 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
Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Exclusion Criteria:
Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
History of seizure during the last 2 years
Subject has any specific cardiac condition or family history of significant cardiac condition
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
19877974
Citation
Spencer TJ, Greenbaum M, Ginsberg LD, Murphy WR. Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):501-10. doi: 10.1089/cap.2008.0152.
Results Reference
result
Links:
URL
http://www.intuniv.com/documents/INTUNIV_Full_Prescribing_Information.pdf
Description
FDA-approved label
Learn more about this trial
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
We'll reach out to this number within 24 hrs