Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT00004376|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: guanfacine||Phase 3|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.
There is a 7- to 14-day washout with a placebo prior to treatment for all patients.
The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.
The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||35 participants|
|Study Start Date :||September 1994|
|Study Completion Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004376
|Study Chair:||Lawrence Scahill||Yale University|