- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004652
Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
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.
Study Overview
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 Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Roger Kurlan, University of Rochester
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Anti-Dyskinesia Agents
- Pimozide
Other Study ID Numbers
- 199/11760
- URMC-418
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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