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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Rochester |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004652 |
Purpose
OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.
II. Determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Tourette Syndrome |
Drug: pimozide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 1993 |
PROTOCOL OUTLINE: This is a combined open label and double blind randomized study.
Patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month.
Then, patients are randomized to one of two possible double blind treatments. In the short term pimozide group, patients receive pimozide over 2 weeks. Then, pimozide is gradually replaced by an inactive placebo within the following 10 weeks.
Patients in the long term pimozide group receive pimozide. Patients continue treatment for 12 months or until a worsening of tics or behavioral symptoms are present for which an increased dosage is required.
Patients who do not experience an exacerbation of tics requiring an increase in dosage are followed for 1 year from the date of entry.
Eligibility| Ages Eligible for Study: | 5 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- DSM-III-R criteria for Tourette syndrome Chronic motor tic disorder with tics sufficiently severe to require neuroleptic therapy --Prior/Concurrent Therapy-- No clonidine for at least 2 weeks or any neuroleptic (e.g., haloperidol, pimozide) within 3 months prior to study Stable dosage of other medications (e.g., antiobsessional, stimulant) for at least 3 months prior to and during study required
Contacts and Locations More Information
| Study ID Numbers: | 199/11760, URMC-418 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004652 |
| Health Authority: | United States: Federal Government |
|
Tourette syndrome neurologic and psychiatric disorders rare disease |
|
Ganglion Cysts Basal Ganglia Diseases Rare Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Brain Diseases Neurodegenerative Diseases Tics |
Dopamine Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Mental Disorders Diagnosed in Childhood Gilles de la Tourette's syndrome Pimozide |
|
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Dopamine Agents Central Nervous System Agents |
