Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
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|ClinicalTrials.gov Identifier: NCT00004652|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: pimozide||Phase 2|
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 :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Study Start Date :||February 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004652
|Study Chair:||Roger Kurlan||University of Rochester|