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Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

Tourette Syndrome Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004393
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date July 1997
Completion date September 2000
View Details
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