Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004376
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
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 Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder and attention deficit hyperactivity disorder
I Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder and attention deficit hyperactivity disorder
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by pubertal status
There is a 7- to 14-day washout with a placebo prior to treatment for all patients
The first group receives oral guanfacine 3 times a day for 8 weeks The dose is gradually increased to minimize sedation by day 14 most patients are stabilized and the dose is then increased as clinically indicated and tolerated
The second group receives a placebo 3 times a day for 8 weeks Patients in either group may be treated with guanfacine for an additional 8 weeks
There is a 7- to 14-day washout with a placebo prior to treatment for all patients
The first group receives oral guanfacine 3 times a day for 8 weeks The dose is gradually increased to minimize sedation by day 14 most patients are stabilized and the dose is then increased as clinically indicated and tolerated
The second group receives a placebo 3 times a day for 8 weeks Patients in either group may be treated with guanfacine for an additional 8 weeks
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-7588 | None | None | None |