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

Tourette Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004393
• Other study ID #: 199/12217
• Secondary ID: YALESM-7764
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: July 1997
• Est. completion date: September 2000

Study information

• Verified date: March 2001
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 60 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

DSM-IV diagnosis of Tourette Syndrome (TS)

Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS

--Prior/Concurrent Therapy--

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

--Patient Characteristics--

Hepatic: No hepatic disease

Renal: No renal disease

Cardiovascular:

• No heart disease

• No hypertension

Pulmonary: No pulmonary disease

Other:

• Not pregnant

• IQ at least 70 required

• No other movement disorder allowed, such as tardive dyskinesia

• No major depression

• No pervasive developmental disorder

• No autism or psychotic disorder based on DSM-IV

• No alcohol or substance abuse

• No hypersensitivity to risperidone

• All subjects must be in good health

Study Design

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

Related Conditions & MeSH terms

• Tourette Syndrome

Intervention

Drug:
• risperidone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Yale University