|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
Yale University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004393 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tourette Syndrome |
Drug: risperidone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 1997 |
| Estimated Study Completion Date: | September 2000 |
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.
Eligibility| Ages Eligible for Study: | 7 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Pulmonary: No pulmonary disease
Other:
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00004393 History of Changes |
| Other Study ID Numbers: | 199/12217, YALESM-7764 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Tourette syndrome neurologic and psychiatric disorders rare disease |
|
Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mental Disorders Diagnosed in Childhood Mental Disorders Risperidone Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
