Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

Completed · Phase 3

Conditions studied: Advanced Parkinson's Disease

In brief

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 with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

Key facts

Study ID

NCT00660673

Run by

AbbVie

People needed

262

Starts

2009-11-13

Expected to finish

2021-11-30

Last updated by the study team

2022-12-02

Who can join

Age: 30 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Research Center of Southern California /ID# 49928 — Encinitas, California, United States
• The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915 — Fountain Valley, California, United States
• Universtiy of Southern California /ID# 49913 — Los Angeles, California, United States
• Colorado Neurological Institute /ID# 49927 — Englewood, Colorado, United States
• Georgetown University Hospital /ID# 49931 — Washington D.C., District of Columbia, United States
• Bradenton Research Center, Inc /ID# 49929 — Bradenton, Florida, United States
• Neurologic Consultants, PA /ID# 49918 — Fort Lauderdale, Florida, United States
• University of Florida - Archer /ID# 49935 — Gainesville, Florida, United States
• University of Florida /ID# 49922 — Jacksonville, Florida, United States
• Charlotte Neurological Service /ID# 49916 — Port Charlotte, Florida, United States
• University of South Florida /ID# 49919 — Tampa, Florida, United States
• Georgia Regents University /ID# 49938 — Augusta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 49944 — Chicago, Illinois, United States
• Rush University Medical Center /ID# 49930 — Chicago, Illinois, United States
• University of Kentucky Chandler Medical Center /ID# 49940 — Lexington, Kentucky, United States
• Louisiana State Univ HSC /ID# 49945 — Shreveport, Louisiana, United States
• Univ Maryland School Medicine /ID# 49934 — Baltimore, Maryland, United States
• Johns Hopkins University /ID# 49937 — Baltimore, Maryland, United States
• Washington University-School of Medicine /ID# 49933 — St Louis, Missouri, United States
• University of Nebraska Medical Center /ID# 49911 — Omaha, Nebraska, United States
• North Shore University Hospital /ID# 49932 — Manhasset, New York, United States
• The Mount Sinai Hospital /ID# 49942 — New York, New York, United States
• Columbia Univ Medical Center /ID# 49943 — New York, New York, United States
• Raleigh Neurology Associates /ID# 49923 — Raleigh, North Carolina, United States
• University of Alabama at Birmingham /ID# 49941 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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