Efficacy and Safety of SPD503 in Combination With Psychostimulants

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734578
• Other study ID #: SPD503-313
• Status: Completed
• Phase: Phase 3
• Start date: September 2, 2008
• Est. completion date: December 10, 2009

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: December 10, 2009
• Est. primary completion date: December 10, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• SPD503-AM
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
• SPD503-PM
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
• Placebo
Placebo matched to Guanfacine Hydrochloride Extended Release

Locations

Country	Name	City	State
United States	FutureSearch Trials	Austin	Texas
United States	Peds Research Inc.	Barnwell	South Carolina
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurobehaviorial Medicine	Bloomfield Hills	Michigan
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	Massachussests General Hospital	Cambridge	Massachusetts
United States	Psychiatric Alliance of the Blue Ridge Clinical Research	Charlottesville	Virginia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Department of Psychiatry, The Ohio State University	Columbus	Ohio
United States	InSite Clinical Research	DeSoto	Texas
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Duke University Medical Center ADHD Program	Durham	North Carolina
United States	Triangle Neuropsychiatry, PLLC	Durham	North Carolina
United States	Valley Clinical Research, Inc.	El Centro	California
United States	Oregon Center for Clinical Investigations, Inc	Eugene	Oregon
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience, Inc	Herndon	Virginia
United States	Claghorn-Lesem Research Clinic, Inc.	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Centers for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Premier Psychiatric Research Inst. LLC	Lincoln	Nebraska
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Western Clinical Investigations	Lubbock	Texas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Miami Children's Hospital	Miami	Florida
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	AMR-Baber Research, Inc.	Naperville	Illinois
United States	Pedia Research	Newburgh	Indiana
United States	American Medical Research, Inc	Oak Brook	Illinois
United States	IPS Research	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania
United States	Oregon Center for Clinical Investigations, INC (OCCI, Inc.)	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Alliance Research Group	Richmond	Virginia
United States	Bayou City Research	Richmond	Virginia
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Marc Hertzman, MD, PC	Rockville	Maryland
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Midwest Research Group/St. Charles Psychiatric Associates	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations, Inc	Salem	Oregon
United States	Delmarva Family Resources	Salisbury	Maryland
United States	Cerebral Research, LLC	San Antonio	Texas
United States	UCSD Department of Psychiatry	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Melmed Center	Scottsdale	Arizona
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Children's Specialized Hospital	Toms River	New Jersey
United States	Behavioral Medicine Center	Troy	Michigan
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Wharton Research Center	Wharton	Texas
United States	Elite Clinical Trials, Inc	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wilens TE, Bukstein O, Brams M, Cutler AJ, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012 Ja — View Citation

Outcome

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

External Links

•   FDA Recall Information
•   FDA-approved Label