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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Attention-Deficit/Hyperactivity Disorder
In brief
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Key facts
- Study ID
- NCT00997984
- Run by
- Shire
- People needed
- 340
- Starts
- 2009-11-17
- Expected to finish
- 2010-10-09
- Last updated by the study team
- 2021-06-08
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 6-12 years old
- ADHD diagnosis
- ADHD-RS-IV minimum score of 28
- CGI-S score > or = 4
You may not qualify if…
- Current, controlled or uncontrolled, comorbid psychiatric diagnosis
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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