Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
NCT ID: NCT00660387
Last Updated: 2015-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2009-12-31
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/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/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# 45931
Birmingham, Alabama, United States
Site Reference ID/Investigator# 45910
Fountain Valley, California, United States
Site Reference ID/Investigator# 45925
Oceanside, California, United States
Site Reference ID/Investigator# 45912
Port Charlotte, Florida, United States
Site Reference ID/Investigator# 45935
Chicago, Illinois, United States
Site Reference ID/Investigator# 45930
Lexington, Kentucky, United States
Site Reference ID/Investigator# 45934
New York, New York, United States
Site Reference ID/Investigator# 45929
Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 45908
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 45922
Cleveland, Ohio, United States
Site Reference ID/Investigator# 45915
Kirkland, Washington, United States
Site Reference ID/Investigator# 45904
Auckland, , New Zealand
Site Reference ID/Investigator# 45902
Christchurch, , New Zealand
Site Reference ID/Investigator# 45905
Hamilton, , New Zealand
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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2007-003814-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S187.3.002
Identifier Type: -
Identifier Source: org_study_id
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