At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
Levodopa-carbidopa intestinal gel +3 moredrug
Likely dose
Levodopa-carbidopa intestinal gel 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.
Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
In Brief
A Phase 3 clinical trial evaluating Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, and 2 other interventions for Dyskinesias and 2 related conditions. Completed, enrolled 62 participants across 22 sites in 3 countries.
Detailed Summary
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyskinesias, Parkinson's Disease, Severe Motor Fluctuations
CountriesGermany, New Zealand, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartJun 2009
Primary CompletionOct 2012
TodayJul 2026
First PostedAug 4, 2006
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.9 years ago
Interventions
Levodopa-carbidopa intestinal geldrug
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 pumpdevice
PEG tubedevice
percutaneous endoscopic gastrostomy tube
J-tubedevice
jejunal tube