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

Descriptive Information
Brief Title ^†	Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
Official Title ^†
Brief Summary	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	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 Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Allocation: Randomized, Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Tourette Syndrome
Intervention ^†	Drugpimozide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	20
Start Date ^†	February 1993
Completion Date
Primary Completion Date
Eligibility 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
Gender	Both
Ages	5 Years - 11 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004652
Organization ID	199/11760
Secondary IDs ^††	URMC-418
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	University of Rochester
Investigators ^†	Study Chair: Roger Kurlan, University of Rochester
Information Provided By	Office of Rare Diseases (ORD)
Verification Date	December 2001
First Received Date ^†	February 24, 2000
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.