Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tourette Syndrome
Intervention: pimozide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Roger Kurlan, Study Chair, Affiliation: University of Rochester
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.
Clinical Details
Study design: Allocation: Randomized, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 5 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Short-term versus longer term pimozide therapy in Tourette's syndrome: a preliminary study. Neurology. 1999 Mar 10;52(4):874-7.
Starting date: February 1993
Last updated: June 23, 2005
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