CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 262 enrolled
Drug / intervention
Levodopa-Carbidopa Intestinal Gel (LCIG) +2 moredrug
Likely dose
Levodopa-Carbidopa Intestinal Gel (LCIG) 20 mgfrom 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.

Search/NCT00660673
NCT00660673Phase 3Completed
CompareCT.gov

Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

AbbVie·interventional·Posted Apr 17, 2008·Updated Dec 2, 2022

In Brief

A Phase 3 clinical trial evaluating Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy® 1400 ambulatory infusion pump, and 1 other intervention for Advanced Parkinson's Disease. Completed, enrolled 262 participants across 61 sites in 11 countries.

Detailed Summary

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
CountriesAustralia, Canada, Czechia, Israel, New Zealand, Poland, Portugal, Russia, Thailand, United Kingdom, United States
CollaboratorsIQVIA, formerly Quintiles

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartNov 13, 2009
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 12.0 yearsPosted 18.2 years ago

Interventions

Levodopa-Carbidopa Intestinal Gel (LCIG)drug

LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.

CADD-Legacy® 1400 ambulatory infusion pumpdevice

Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.

Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)device

All participants previously had a PEG-J placed in one of the prior LCIG studies.