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

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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).


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
4202 East Fowler Avenue
Tampa, Florida 33613
2135
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from 91732
Tampa, FL
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Augusta, Georgia 30912
?
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Augusta, GA
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100 Penn Street
Baltimore, Maryland 21201
2301
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Baltimore, MD
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Baltimore, Maryland 21287
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Baltimore, MD
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Birmingham, Alabama 35233
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Birmingham, AL
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3924 9th Avenue West
Bradenton, Florida 34205
2139
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Bradenton, FL
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?
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Burlington, VT
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303 East Superior Street
Chicago, Illinois 60611
1730
mi
from 91732
Chicago, IL
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1653 West Congress Parkway
Chicago, Illinois 60612
1727
mi
from 91732
Chicago, IL
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Cincinnati, Ohio 45267
?
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from 91732
Cincinnati, OH
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9500 Euclid Avenue
Cleveland, Ohio 44195
2036
mi
from 91732
Cleveland, OH
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Encinitas, California 92024
?
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Encinitas, CA
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Englewood, Colorado 80113
?
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Englewood, CO
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1841 Northeast 45th Street
Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
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Fountain Valley, California 92708
?
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Fountain Valley, CA
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Gainesville, Florida 32607
2100
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from 91732
Gainesville, FL
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Jacksonville, Florida 32209
2139
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from 91732
Jacksonville, FL
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Kirkland, Washington 98034
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Kirkland, WA
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?
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Lexington, KY
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Los Angeles, California 90033
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Los Angeles, CA
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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New Hyde Park, New York 11040
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New Hyde Park, NY
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New York, New York 10029
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New York, NY
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2435
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from 91732
New York, NY
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1298
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Omaha, NE
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Port Charlotte, Florida 33980
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Port Charlotte, FL
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1540 Sunday Drive
Raleigh, North Carolina 27607
2213
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Raleigh, NC
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660 South Euclid Avenue
Saint Louis, Missouri 63110
1569
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from 91732
Saint Louis, MO
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Shreveport, Louisiana 71130
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Shreveport, LA
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Washington, District of Columbia 20007
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Washington,
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Westmead, New South Wales
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Westmead,
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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