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Phase II Pilot Controlled Study of Short vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome



Phase II Pilot Controlled Study of Short vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome

For Condition: Tourette Syndrome
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Rochester
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 5 Years/11 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
RogerKurlan,  Study Chair,  University of Rochester


Additional Information:
Study ID Numbers:  199/11760;  URMC-418
Study Start Date: February 1993
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004652

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4. Central Mechanisms in Speech Motor Control Studied with H215O PET

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