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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

NCT01736176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-07-16

Study results available
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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

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.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Janet Benesh, BS · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-03-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736176 on ClinicalTrials.gov