NCT01736176

A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa-Carbidopa Intestinal Gel	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.
PROCEDURE	Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)
DRUG	Levodopa-carbidopa Immediate Release (LC-IR) Tablets	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-12-01
• First posted: 2012-11-29
• Last updated: 2021-07-16
• Results posted: 2017-02-08