Completed

Pimozide Therapy in Tourette Syndrome: Short vs Long Term

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What is being tested

pimozide

Drug
Who is being recruted

Basal Ganglia Diseases+16

+ Brain Diseases

+ Central Nervous System Diseases

From 5 to 11 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1993
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00004652
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsTic DisordersNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemDisease AttributesGenetic Diseases, InbornNeurodevelopmental DisordersMental DisordersTourette SyndromeNeurologic ManifestationsRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers