NCT00004393

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 1997

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2001

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Tourette Syndrome

Keywords

Tourette syndromeneurologic and psychiatric disordersrare disease

Interventions

risperidoneDRUG

Eligibility Criteria

Age7 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Tourette SyndromeNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bradley S. Peterson

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

July 1, 1997

Study Completion

September 1, 2000

Last Updated

June 24, 2005

Record last verified: 2001-03