Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
|Brief Title †||Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome|
|Official Title †|
OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome.
II. Evaluate further the safety of RIS in this population.
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study.
Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated.
Patients continue RIS for 4 additional weeks at the dose prescribed during week 4.
All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.
|Study Phase||Phase 2|
|Study Type †||Interventional|
|Study Design †||Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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 †||50|
|Start Date †||July 1997|
|Completion Date||September 2000|
|Primary Completion Date|
|Eligibility Criteria †||
PROTOCOL ENTRY CRITERIA:
DSM-IV diagnosis of Tourette Syndrome (TS)
Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS
No concurrent use of other medications during study
A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine
Hepatic: No hepatic disease
Renal: No renal disease
|Ages||7 Years - 60 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †|
|NCT ID †||NCT00004393|
|Secondary IDs ††||YALESM-7764|
|Study Sponsor †||National Center for Research Resources (NCRR)|
|Investigators †||Study Chair: Bradley S. Peterson, 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.