Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004652
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide Orap Therapy in Tourette Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URMC-418 | None | None | None |