Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004393
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Double Blind Placebo Controlled Trial of Risperidone 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:
2001-03
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 Conduct a randomized double blind placebo controlled parallel study of the atypical neuroleptic risperidone RIS in the treatment of children and adults with moderate to severe Tourette Syndrome
II Evaluate further the safety of RIS in this population
II Evaluate further the safety of RIS in this population
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Initially all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study
Then patients are randomized to receive either risperidone RIS or placebo for 8 weeks The dose of RIS is increased weekly over the first 4 weeks of treatment as tolerated
Patients continue RIS for 4 additional weeks at the dose prescribed during week 4
All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase and at the end of weeks 2 4 6 and 8 of the active treatment phase
Then patients are randomized to receive either risperidone RIS or placebo for 8 weeks The dose of RIS is increased weekly over the first 4 weeks of treatment as tolerated
Patients continue RIS for 4 additional weeks at the dose prescribed during week 4
All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase and at the end of weeks 2 4 6 and 8 of the active treatment phase
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 |
|---|---|---|---|
| YALESM-7764 | None | None | None |