Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360568
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2006-08-03
Brief Title:
SafetyEfficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinsons Subjects
Sponsor:
AbbVie prior sponsor Abbott
Organization:
AbbVie
Study Overview
Official Title:
Open-Label 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinsons 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 S1873003 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 Parkinsons 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 S1873001 or S1873002 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 S1873001 or S1873002 NCT00357994 NCT00660387 qualified for enrollment in this 12-month continuation treatment study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-000578-53 | EUDRACT_NUMBER | None | None |