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

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Brief Title

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

Brief 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.

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.

Study Phase

Phase 2

Study Type

Interventional

Condition

Tourette Syndrome

Intervention

pimozide

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

February 1993

Eligibility 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

Gender

All

Ages

5 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

Roger Kurlan, ,

Administrative Informations

NCT ID

NCT00004652

Organization ID

199/11760

Secondary IDs

URMC-418

Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 University of Rochester

Study Sponsor

Roger Kurlan, Study Chair, University of Rochester

Verification Date

December 2001