Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson’s Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Sponsor:

Brief Summary:

The primary objective is to provide continued access to subjects who would like to continue
levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003
or S187.3.004).

Criteria

Inclusion Criteria:

– The subject 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, subjects 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 subject 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
subject does not have the capacity to provide informed consent, full informed consent
must be obtained from the subject’s legally authorized representative. Consenting will
be performed according to local regulations.

Exclusion Criteria:

– Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be
clinically significant and which could interfere with the subjects participation in
the study.

Locations

The Research Ctr Southern CA /ID# 49928, Carlsbad, California, United States, 92011-4219
Parkinson’s and Movement /ID# 49915, Fountain Valley, California, United States, 92708
Usc /Id# 49913, Los Angeles, California, United States, 90033