At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 36 enrolled
Drug / intervention
Levodopa carbidopa intestinal gel (LCIG) +6 moredrug
Likely dose
Levodopa carbidopa intestinal gel (LCIG) 10 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations
In Brief
A Phase 3 clinical trial evaluating Levodopa carbidopa intestinal gel (LCIG), Placebo gel, and 5 other interventions for Advanced Parkinson's Disease. Completed, enrolled 36 participants across 15 sites in 2 countries.
Detailed Summary
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
CountriesGermany, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2006
Enrollment StartJan 2009
Primary CompletionOct 2011
TodayJul 2026
First PostedJul 28, 2006
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.9 years ago
Interventions
Levodopa carbidopa intestinal gel (LCIG)drug
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 geldrug
Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tabletsdrug
Placebo (PBO) oral capsulesdrug
CADD-Legacy® 1400 ambulatory infusion pumpdevice
PEG tubedevice
percutaneous endoscopic gastrostomy tube
J-tubedevice
jejunal tube