Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
Status: | Active, not recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 99 |
Updated: | 12/16/2018 |
Start Date: | November 13, 2009 |
End Date: | September 30, 2020 |
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
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).
levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003
or S187.3.004).
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.
We found this trial at
32
sites
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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