|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) 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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| 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
| Study ID Numbers: | 199/12217, YALESM-7764 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004393 History of Changes |
| Health Authority: | United States: Federal Government |
|
Tourette syndrome neurologic and psychiatric disorders rare disease |
|
Neurotransmitter Agents Tranquilizing Agents Ganglion Cysts Basal Ganglia Diseases Psychotropic Drugs Risperidone Rare Diseases Central Nervous System Depressants Central Nervous System Diseases Tourette Syndrome Tic Disorders Antipsychotic Agents |
Brain Diseases Neurodegenerative Diseases Serotonin Tics Dopamine Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Mental Disorders Diagnosed in Childhood Dopamine Agents |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Physiological Effects of Drugs Psychotropic Drugs Neurodegenerative Diseases Brain Diseases Serotonin Antagonists Heredodegenerative Disorders, Nervous System Pathologic Processes Movement Disorders Mental Disorders Therapeutic Uses Syndrome Mental Disorders Diagnosed in Childhood |
Disease Tranquilizing Agents Nervous System Diseases Risperidone Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Tourette Syndrome Tic Disorders Antipsychotic Agents Pharmacologic Actions Serotonin Agents Genetic Diseases, Inborn Dopamine Agents Central Nervous System Agents |
