Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
|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)|
|Estimated Enrollment :||35 participants|
|Study Start Date :||September 1994|
|Estimated Study Completion Date :||June 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004376
|Study Chair:||Lawrence Scahill||Yale University|