Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
NCT ID: NCT00997984
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2009-11-17
2010-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Extended-release Guanfacine Hydrochloride (SPD503) AM
extended-release guanfacine hydrochloride (SPD503)
dosed in AM
placebo
placebo
dosed in the AM or PM
SPD503 PM
extended-release guanfacine hydrochloride
Dosed in the PM
Interventions
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extended-release guanfacine hydrochloride (SPD503)
dosed in AM
placebo
dosed in the AM or PM
extended-release guanfacine hydrochloride
Dosed in the PM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ADHD diagnosis
* ADHD-RS-IV minimum score of 28
* CGI-S score \> or = 4
Exclusion Criteria
* Condition or illness which represent inappropriate risk to subject
* Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension
* Use of prohibited medication that have CNS effects or affect cognitive performance
* History of alcohol or substance abuse within 6 months
* Current use of medication that affect BP or heart rate
* Significantly overweight
* Weight of less than 55 lbs
* Known allergy to SPD503
* Abnormal urine drug and alcohol screen
6 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
El Centro, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Psychiatric centers at San Diego, Feighner Research
San Diego, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Janus Centerfor Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Clincial Research Group
Marietta, Georgia, United States
Mountain West Clinical Trials
Boise, Idaho, United States
University of Illinois Chicago
Chicago, Illinois, United States
American Medical research, Inc.
Oak Brook, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Clinco
Terre Haute, Indiana, United States
Psychiatric Associates
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Marc Hertzman, M.D., P.C.
Rockville, Maryland, United States
Richester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Midwest research Group
Saint Charles, Missouri, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Children's Specialized Hospital
Toms River, New Jersey, United States
Innovis Health
Fargo, North Dakota, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials
Austin, Texas, United States
Claghorn-Lesem research Clinic
Houston, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Western Clinical Investigations
Lubbock, Texas, United States
Cerebral Research, LLC
San Antonio, Texas, United States
Vermont Clinical Study Center
Burlington, Vermont, United States
NeuroScience Inc
Herndon, Virginia, United States
Alliance Research Group, LLC
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
BC Women;s Hospital and Health Centre
Vancouver, British Columbia, Canada
Toronto ADHD Clinic
Toronto, Ontario, Canada
ADHD Clinical/ The Kids Clinic
Whitby, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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References
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Newcorn JH, Stein MA, Childress AC, Youcha S, White C, Enright G, Rubin J. Randomized, double-blind trial of guanfacine extended release in children with attention-deficit/hyperactivity disorder: morning or evening administration. J Am Acad Child Adolesc Psychiatry. 2013 Sep;52(9):921-30. doi: 10.1016/j.jaac.2013.06.006. Epub 2013 Aug 1.
Stein MA, Sikirica V, Weiss MD, Robertson B, Lyne A, Newcorn JH. Does Guanfacine Extended Release Impact Functional Impairment in Children with Attention-Deficit/Hyperactivity Disorder? Results from a Randomized Controlled Trial. CNS Drugs. 2015 Nov;29(11):953-62. doi: 10.1007/s40263-015-0291-6.
Other Identifiers
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SPD503-314
Identifier Type: -
Identifier Source: org_study_id
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