Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
NCT ID: NCT00360568
Last Updated: 2015-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2009-06-30
2012-10-31
Brief Summary
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Detailed Description
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Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levodopa-Carbidopa Intestinal Gel (LCIG)
All participants received LCIG, delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks).
Starting dose of LCIG was based on the participant's optimized oral levodopa-carbidopa dose that the subject was receiving just prior to randomization in Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of either of these 2 previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Levodopa-carbidopa intestinal gel
Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
CADD-Legacy® 1400 ambulatory infusion pump
PEG tube
percutaneous endoscopic gastrostomy tube
J-tube
jejunal tube
Interventions
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Levodopa-carbidopa intestinal gel
Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
CADD-Legacy® 1400 ambulatory infusion pump
PEG tube
percutaneous endoscopic gastrostomy tube
J-tube
jejunal tube
Eligibility Criteria
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Inclusion Criteria
* Levodopa-responsive with severe motor fluctuations
Exclusion Criteria
30 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Janet Benesh
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 45869
Birmingham, Alabama, United States
Site Reference ID/Investigator# 45834
Fountain Valley, California, United States
Site Reference ID/Investigator# 45854
Los Angeles, California, United States
Site Reference ID/Investigator# 45856
Oceanside, California, United States
Site Reference ID/Investigator# 45859
Washington D.C., District of Columbia, United States
Site Reference ID/Investigator# 45857
Bradenton, Florida, United States
Site Reference ID/Investigator# 45863
Gainesville, Florida, United States
Site Reference ID/Investigator# 45836
Port Charlotte, Florida, United States
Site Reference ID/Investigator# 45874
Chicago, Illinois, United States
Site Reference ID/Investigator# 45868
Lexington, Kentucky, United States
Site Reference ID/Investigator# 45862
Baltimore, Maryland, United States
Site Reference ID/Investigator# 45861
St Louis, Missouri, United States
Site Reference ID/Investigator# 45873
New York, New York, United States
Site Reference ID/Investigator# 45878
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 45850
Cleveland, Ohio, United States
Site Reference ID/Investigator# 45887
Burlington, Vermont, United States
Site Reference ID/Investigator# 45828
Bochum, , Germany
Site Reference ID/Investigator# 45829
Bremerhaven, , Germany
Site Reference ID/Investigator# 45825
Hanover, , Germany
Site Reference ID/Investigator# 54402
Tübingen, , Germany
Site Reference ID/Investigator# 45884
Auckland, , New Zealand
Site Reference ID/Investigator# 45885
Hamilton, , New Zealand
Countries
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Related Links
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Related Info
Other Identifiers
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2006-000578-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S187.3.003
Identifier Type: -
Identifier Source: org_study_id
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