Back to resultsSafety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPD503 (Guanfacine HCl)
Placebo
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 Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4 Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Subject weighs > 55 lbs and is not morbidly overweight Exclusion Criteria: Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders Subject has a history of seizure disorder Subject has any specific cardiac condition or family history of significant cardiac condition Subject is pregnant, lactating or within six month post-partum
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SPD503 (Guanfacine HCl)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
Secondary Outcome Measures
Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.
Change From Baseline in 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.
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 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.
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 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.
Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150592
Brief Title
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Official Title
A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to 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
May 12, 2005 (Actual)
Primary Completion Date
October 5, 2005 (Actual)
Study Completion Date
October 5, 2005 (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 effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD503 (Guanfacine HCl)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD503 (Guanfacine HCl)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks
Description
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years
Description
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years
Description
The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks
Description
The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in 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
Title
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks
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 Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks
Description
The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.
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
Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Subject weighs > 55 lbs and is not morbidly overweight
Exclusion Criteria:
Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
Subject has a history of seizure disorder
Subject has any specific cardiac condition or family history of significant cardiac condition
Subject is pregnant, lactating or within six month post-partum
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
21476931
Citation
Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.
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
Learn more about this trial
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
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