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A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

NCT02549092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-11-28

Study results available
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Summary

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

Optimized Medical Treatment

Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.

DRUG

Levodopa-Carbidopa Intestinal Gel

DEVICE

Nasojejunal (NJ) tube

optional prior to PEG-J placement

DEVICE

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2020-05-14
Completion
2022-11-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Greece
  • Italy
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

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 NCT02549092 on ClinicalTrials.gov