SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
1 other identifier
interventional
217
1 country
34
Brief Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
34 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 22, 2006
CompletedFirst Posted
Study publicly available on registry
August 23, 2006
CompletedStudy Start
First participant enrolled
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2008
CompletedResults Posted
Study results publicly available
November 26, 2009
CompletedJune 14, 2021
June 1, 2021
1.1 years
August 22, 2006
September 10, 2009
June 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at 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.
Baseline and up to 8 weeks
Secondary Outcomes (10)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks
Baseline and up to 8 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S)
up to 8 weeks
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
up to 8 weeks
Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks
Baseline and up to 8 weeks
Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks
Baseline and up to 8 weeks
- +5 more secondary outcomes
Study Arms (2)
SPD503 (Guanfacine hydrochloride)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
Eligibility Criteria
You may qualify if:
- Healthy subjects with ADHD and oppositional symptoms
- ADHD-RS\>=24
- CGI \>=4
- T-score of Opp subscale CPRS-R:L \>=65
- Normal ECG and BP
- \>= 55 lbs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (34)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Valley Clinical Research
El Centro, California, 92243, United States
Peninsula Research Associates Inc
Rolling Hills Estates, California, 90274, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
University of Florida
Gainesville, Florida, 32610, United States
Amedica Research Institute, Inc
Hialeah, Florida, 33013, United States
CORE Research, Inc
Maitland, Florida, 32751, United States
Miami Research Associates
Miami, Florida, 33143, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806, United States
Childrens Developmental Center
Winter Park, Florida, 32792, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Pedia Research
Owensboro, Kentucky, 42301, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
CRI Worldwide, LLC
Clementon, New Jersey, 08021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Rochester, School of Medicine and Dentistry
Rochester, New York, 14618, United States
SUNY Upsate Medical University
Syracuse, New York, 13210, United States
Piedmont Neuropsychiatry
Charlotte, North Carolina, 28226, United States
Duke Child & Family Study Center
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Discovery and Wellness Center for Children
Cleveland, Ohio, 44106, United States
BHI Inc
Moore, Oklahoma, 73160, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, 97301, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19149, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Claghorn-Lesem Research Clinic Inc
Houston, Texas, 77008, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
NeuroScience, Inc
Herndon, Virginia, 20170, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Related Publications (1)
Connor DF, Findling RL, Kollins SH, Sallee F, Lopez FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010 Sep;24(9):755-68. doi: 10.2165/11537790-000000000-00000.
PMID: 20806988RESULT
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 22, 2006
First Posted
August 23, 2006
Study Start
December 4, 2006
Primary Completion
January 4, 2008
Study Completion
January 4, 2008
Last Updated
June 14, 2021
Results First Posted
November 26, 2009
Record last verified: 2021-06