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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00150592
First received: September 6, 2005
Last updated: May 6, 2011
Last verified: May 2011
  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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014