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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tourette Syndrome

Intervention: pimozide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Roger Kurlan, Study Chair, Affiliation: University of Rochester

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Primary Purpose: Treatment

Detailed description: 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

Minimum age: 5 Years. Maximum age: 11 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Related publications:

Short-term versus longer term pimozide therapy in Tourette's syndrome: a preliminary study. Neurology. 1999 Mar 10;52(4):874-7.

Starting date: February 1993
Last updated: June 23, 2005

Page last updated: August 23, 2015

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