Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
NCT ID: NCT00357994
Last Updated: 2015-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2009-01-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules
Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
Levodopa carbidopa intestinal gel (LCIG)
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 per/hour)
Placebo (PBO) oral capsules
CADD-Legacy® 1400 ambulatory infusion pump
PEG tube
percutaneous endoscopic gastrostomy tube
J-tube
jejunal tube
Placebo Gel + Levodopa-Carbidopa Capsules
Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Placebo gel
Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
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 (LCIG)
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 per/hour)
Placebo gel
Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
Placebo (PBO) oral capsules
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 participants who demonstrate some identifiable 'on response,' established by Investigator observation
* Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated
Exclusion Criteria
* Undergone surgery for the treatment of PD
* Contraindications to levodopa
* Subjects with any neurological deficit that may interfere with the study assessments
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# 45719
Los Angeles, California, United States
Site Reference ID/Investigator# 45718
Englewood, Colorado, United States
Site Reference ID/Investigator# 45722
Washington D.C., District of Columbia, United States
Site Reference ID/Investigator# 45721
Bradenton, Florida, United States
Site Reference ID/Investigator# 45705
Gainesville, Florida, United States
Site Reference ID/Investigator# 45740
Baltimore, Maryland, United States
Site Reference ID/Investigator# 45739
St Louis, Missouri, United States
Site Reference ID/Investigator# 45703
Burlington, Vermont, United States
Site Reference ID/Investigator# 44970
Bochum, , Germany
Site Reference ID/Investigator# 44971
Bremerhaven, , Germany
Site Reference ID/Investigator# 44973
Dresden, , Germany
Site Reference ID/Investigator# 44965
Hanover, , Germany
Site Reference ID/Investigator# 44964
Kiel, , Germany
Site Reference ID/Investigator# 44966
Marburg, , Germany
Site Reference ID/Investigator# 44968
Tübingen, , Germany
Countries
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References
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Shih TM, Sail KR, Jalundhwala YJ, Sullivan J, van Eijndhoven E, Zadikoff C, Marshall TS, Lakdawalla DN. The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson's disease. J Med Econ. 2020 Mar;23(3):297-307. doi: 10.1080/13696998.2019.1693383. Epub 2019 Nov 28.
Lew MF, Slevin JT, Kruger R, Martinez Castrillo JC, Chatamra K, Dubow JS, Robieson WZ, Benesh JA, Fung VS. Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials. Parkinsonism Relat Disord. 2015 Jul;21(7):742-8. doi: 10.1016/j.parkreldis.2015.04.022. Epub 2015 Apr 28.
Olanow CW, Kieburtz K, Odin P, Espay AJ, Standaert DG, Fernandez HH, Vanagunas A, Othman AA, Widnell KL, Robieson WZ, Pritchett Y, Chatamra K, Benesh J, Lenz RA, Antonini A; LCIG Horizon Study Group. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014 Feb;13(2):141-9. doi: 10.1016/S1474-4422(13)70293-X. Epub 2013 Dec 20.
Related Links
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Related Info
Other Identifiers
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2006-000577-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S187.3.001
Identifier Type: -
Identifier Source: org_study_id
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