Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00150592
First received: September 6, 2005
Last updated: May 6, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: SPD503 (Guanfacine HCl) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 182 |
| Study Start Date: | May 2005 |
| Study Completion Date: | April 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SPD503 (Guanfacine HCl) | Drug: SPD503 (Guanfacine HCl) |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00150592 History of Changes |
| Other Study ID Numbers: | SPD503-206 |
| Study First Received: | September 6, 2005 |
| Results First Received: | September 10, 2009 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Guanfacine Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013