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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-02-28

Brief Summary

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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

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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.

Conditions

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Tourette Syndrome

Keywords

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Tourette syndrome neurologic and psychiatric disorders rare disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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pimozide

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roger Kurlan

Role: STUDY_CHAIR

University of Rochester

References

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Short-term versus longer term pimozide therapy in Tourette's syndrome: a preliminary study. Neurology. 1999 Mar 10;52(4):874-7. doi: 10.1212/wnl.52.4.874.

Reference Type BACKGROUND

PMID: 10078748 (View on PubMed)

Other Identifiers

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URMC-418

Identifier Type: -

Identifier Source: secondary_id

199/11760