Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004433
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Pergolide in Children With Tourette Syndrome
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-03
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 Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome GTS
II Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics
III Determine efficacy of pergolide for tic control in these patients
I Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome GTS
II Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics
III Determine efficacy of pergolide for tic control in these patients
Detailed Description:
PROTOCOL OUTLINE
This is a three part study part I is a randomized double blind fixed single dose study part II is a randomized open label stratified study and part III is a randomized double blind placebo controlled study
Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks Part II patients are randomized to receive either low or high dose pergolide for 4 weeks
Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in Total treatment duration is 16 weeks
Patients are followed at 6 months
Completion date provided represents the completion date of the grant per OOPD records
This is a three part study part I is a randomized double blind fixed single dose study part II is a randomized open label stratified study and part III is a randomized double blind placebo controlled study
Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks Part II patients are randomized to receive either low or high dose pergolide for 4 weeks
Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in Total treatment duration is 16 weeks
Patients are followed at 6 months
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| MUSC-FDR001111 | None | None | None |
| MUSC-6130 | None | None | None |