Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
|Brief Title †||Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder|
|Official Title †|
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.
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 Phase||Phase 3|
|Study Type †||Interventional|
|Study Design †||Primary Purpose: Treatment|
|Primary Outcome Measure †|
|Secondary Outcome Measure †|
|Study Arms / Comparison Groups|
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †||Drug|
|Estimated Enrollment †||35|
|Start Date †||September 1994|
|Completion Date||June 2000|
|Primary Completion Date|
|Eligibility Criteria †||
PROTOCOL ENTRY CRITERIA:
|Ages||7 Years - 16 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †|
|NCT ID †||NCT00004376|
|Secondary IDs ††||YALESM-7588|
|Study Sponsor †||National Center for Research Resources (NCRR)|
|Investigators †||Study Chair: Lawrence Scahill, Yale University|
|Information Provided By||Office of Rare Diseases (ORD)|
|Verification Date||March 2001|
|First Received Date †||October 18, 1999|
|Last Updated Date||June 23, 2005|
†† WHO trial registration data element that is required only if it exists.