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Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
This study has been completed.
Study NCT00004652   Information provided by Office of Rare Diseases (ORD)
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
February 1993
 
 
 
Complete list of historical versions of study NCT00004652 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase II
Interventional
Treatment, Randomized
Tourette Syndrome
Drug: pimozide
 
[No authors listed] Short-term versus longer term pimozide therapy in Tourette's syndrome: a preliminary study. Neurology. 1999 Mar 10;52(4):874-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
 
 

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

Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004652
 
199/11760, URMC-418
National Center for Research Resources (NCRR)
University of Rochester
Study Chair: Roger Kurlan University of Rochester
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP