Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 10:23 AM
Study NCT ID:
NCT00360568
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2006-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Sponsor:
AbbVie (prior sponsor, Abbott)
Organization:
Study Overview
Official Title:
Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
Status:
COMPLETED
Status Verified Date:
2015-01
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:
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
Detailed Description:
Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG.
Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.
Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2006-000578-53 | EUDRACT_NUMBER | None | View |