Status:
COMPLETED
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Lead Sponsor:
AbbVie
Collaborating Sponsors:
IQVIA, formerly Quintiles
Conditions:
Advanced Parkinson's Disease
Eligibility:
30-99 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study...
Eligibility Criteria
Inclusion
- The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
- For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
- The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.
Exclusion
- Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.
Key Trial Info
Start Date :
November 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00660673
Start Date
November 13 2009
End Date
November 30 2021
Last Update
December 2 2022
Active Locations (61)
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1
University of Alabama at Birmingham /ID# 49941
Birmingham, Alabama, United States, 35294
2
The Research Center of Southern California /ID# 49928
Encinitas, California, United States, 92024
3
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915
Fountain Valley, California, United States, 92708
4
Universtiy of Southern California /ID# 49913
Los Angeles, California, United States, 90033