Efficacy and Safety of SPD503 in Combination With Psychostimulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00734578
First received: August 12, 2008
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.


Condition Intervention Phase
ADHD
Drug: SPD503-AM
Drug: SPD503-PM
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF [ Time Frame: Baseline and weekly up to 8 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.

  • Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.

  • Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.

  • Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    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 the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.

  • Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: No ]
    This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.

  • Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF [ Time Frame: Baseline and weekly up to 8 weeks ] [ Designated as safety issue: Yes ]
    Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.


Enrollment: 461
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD503-AM
SPD503 (Guanfacine Extended Release)
Drug: SPD503-AM
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
Other Name: Intuniv
Experimental: SPD503-PM
SPD503 (Guanfacine Extended Release)
Drug: SPD503-PM
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
Other Name: Intuniv
Placebo Comparator: Placebo Drug: Placebo
Placebo matched to Guanfacine Hydrochloride Extended Release

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
  • Aged 6-17 years with a sub-optimal
  • Partial response to stimulants
  • Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734578

  Show 61 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Timothy Wilens Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Wilens TE, Bukstein O, Brams M, et al. Journal of the American Academy of Child & Adolescent Psychiatry; Volume 51, Issue 1 , Pages:74-85.e2, January 2012.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00734578     History of Changes
Other Study ID Numbers: SPD503-313
Study First Received: August 12, 2008
Results First Received: October 22, 2010
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 22, 2014