Efficacy and Safety of SPD503 in Combination With Psychostimulants

Phase 3

Completed

Conditions: ADHD

Interventions: Drug: SPD503-AM
Drug: SPD503-PM
Drug: Placebo

Registration Number: NCT00734578

Lead Sponsor: Shire

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 461

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPD503-AM	SPD503-AM	SPD503 (Guanfacine Extended Release)
SPD503-PM	SPD503-PM	SPD503 (Guanfacine Extended Release)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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)	Baseline and weekly up to 8 weeks	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

Name	Time	Method
Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF	Baseline and week 8	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 Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF	Baseline and weekly up to 8 weeks	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.
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	Baseline and weekly up to 8 weeks	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)
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF	Baseline and weekly up to 8 weeks	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.
Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)	Baseline and weekly up to 8 weeks	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 Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF	Baseline and weekly up to 8 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 Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)	Baseline and weekly up to 8 weeks	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 the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF	Baseline and weekly up to 8 weeks	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.

Trial Locations

Locations (58): Harmonex Neuroscience Research
🇺🇸
Dothan, Alabama, United States
Melmed Center
🇺🇸
Scottsdale, Arizona, United States
Clinical Study Centers, LLC
🇺🇸
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
🇺🇸
El Centro, California, United States
Peninsula Research Associates
🇺🇸
Rolling Hills Estates, California, United States
UCSD Department of Psychiatry
🇺🇸
San Diego, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Elite Clinical Trials, Inc
🇺🇸
Wildomar, California, United States
Florida Clinical Research Center, LLC
🇺🇸
Maitland, Florida, United States
Gulfcoast Clinical Research Center
🇺🇸
Fort Myers, Florida, United States
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Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States