CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Levodopa-Carbidopa Intestinal Gel +2 moredrug
Likely dose
Levodopa-Carbidopa Intestinal Gel 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/NCT01736176
NCT01736176Phase 3Completed
CompareCT.gov

An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease

AbbVie (prior sponsor, Abbott)·interventional·Posted Nov 29, 2012·Updated Jul 16, 2021

In Brief

A Phase 3 clinical trial evaluating Levodopa-Carbidopa Intestinal Gel, Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J), and 1 other intervention for Advanced Parkinson's Disease. Completed, enrolled 39 participants.

Detailed Summary

The primary objective of this study is to evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2012
Enrollment StartMar 1, 2013
Primary CompletionMar 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.6 years ago

Interventions

Levodopa-Carbidopa Intestinal Geldrug

Levodopa-carbidopa intestinal gel (LCIG) for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa monohydrate (5 mg/mL) in an aqueous gel, administered continuously by a portable pump via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube. The rate of LCIG infusion was expected to be within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances over a period of 16 consecutive hours.

Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)procedure

Levodopa-carbidopa Immediate Release (LC-IR) Tabletsdrug

After LCIG initiation, participants could take prescribed oral levodopa-carbidopa immediate or continuous release (i.e., oral LC prescribed by the investigator) for nighttime use.