Efficacy and Safety of SPD503 in Combination With Psychostimulants
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)
1 other identifier
interventional
461
1 country
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
Shorter than P25 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
September 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2009
CompletedResults Posted
Study results publicly available
November 23, 2010
CompletedJune 14, 2021
June 1, 2021
1.3 years
August 12, 2008
October 22, 2010
June 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF
Baseline and weekly up to 8 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Baseline and weekly up to 8 weeks
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
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
Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF
Baseline and week 8
- +3 more secondary outcomes
Study Arms (3)
SPD503-AM
EXPERIMENTALSPD503 (Guanfacine Extended Release)
SPD503-PM
EXPERIMENTALSPD503 (Guanfacine Extended Release)
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (61)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
Melmed Center
Scottsdale, Arizona, 85254, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Valley Clinical Research, Inc.
El Centro, California, 92243, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
UCSD Department of Psychiatry
San Diego, California, 8620, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Elite Clinical Trials, Inc
Wildomar, California, 92595, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 32751, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
AMR-Baber Research, Inc.
Naperville, Illinois, 60563, United States
American Medical Research, Inc
Oak Brook, Illinois, 60523, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Pedia Research
Newburgh, Indiana, 47630, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Marc Hertzman, MD, PC
Rockville, Maryland, 20852, United States
Delmarva Family Resources
Salisbury, Maryland, 21801, United States
Massachussests General Hospital
Cambridge, Massachusetts, 02138, United States
Neurobehaviorial Medicine
Bloomfield Hills, Michigan, 48302, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Behavioral Medicine Center
Troy, Michigan, 48083, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Midwest Research Group/St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301, United States
Premier Psychiatric Research Inst. LLC
Lincoln, Nebraska, 68510, United States
Centers for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128, United States
Children's Specialized Hospital
Toms River, New Jersey, 08755, United States
Bioscience Research, LLC
Mount Kisco, New York, 10549, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Duke University Medical Center ADHD Program
Durham, North Carolina, 27705, United States
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, 27707, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Department of Psychiatry, The Ohio State University
Columbus, Ohio, 43210, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc
Eugene, Oregon, 97401, United States
Oregon Center for Clinical Investigations, INC (OCCI, Inc.)
Portland, Oregon, 97210, United States
Summit Research Network
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, 97301, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15065, United States
Peds Research Inc.
Barnwell, South Carolina, 29812, United States
FutureSearch Trials
Austin, Texas, 75756, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Western Clinical Investigations
Lubbock, Texas, 79423, United States
Cerebral Research, LLC
San Antonio, Texas, 78247, United States
Wharton Research Center
Wharton, Texas, 77488, United States
Vermont Clinical Study Center
Burlington, Vermont, 05401, United States
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc
Herndon, Virginia, 20170, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Alliance Research Group
Richmond, Virginia, 23230, United States
Bayou City Research
Richmond, Virginia, 23230, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Related Publications (2)
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 Jan;51(1):74-85.e2. doi: 10.1016/j.jaac.2011.10.012. Epub 2011 Nov 25.
PMID: 22176941RESULTCutler AJ, Brams M, Bukstein O, Mattingly G, McBurnett K, White C, Rubin J. Response/remission with guanfacine extended-release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1092-101. doi: 10.1016/j.jaac.2014.08.001. Epub 2014 Aug 15.
PMID: 25245353DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
September 2, 2008
Primary Completion
December 10, 2009
Study Completion
December 10, 2009
Last Updated
June 14, 2021
Results First Posted
November 23, 2010
Record last verified: 2021-06