Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective:
To examine the effect of levodopa-carbidopa intestinal gel (LCIG, designated carbidopa-levodopa enteral suspension in the US) treatment relative to that of optimized medical treatment (OMT) on dyskinesia in advanced Parkinson’s disease (PD) patients.
Background:
Prolonged use of oral levodopa therapy in advanced PD patients often leads to painful and disabling dyskinesia. LCIG, delivered continuously via percutaneous gastrojejunostomy, reduces wearing off in advanced PD patients, but data on dyskinesia are limited. The DYSCOVER (dyskinesia comparative interventional trial on LCIG versus oral medication) study will be the first interventional, randomized study investigating the efficacy of LCIG on dyskinesia in advanced PD patients.
Methods:
Sixty LCIG-naïve advanced PD patients with severe motor fluctuations and dyskinesia will be enrolled in movement disorders centers across 6 countries in accordance with local product label. Prior to recruitment, patients will have reached the maximum therapeutic effect of pharmacological anti-PD therapies and have no expectation of further improvement based on the investigator’s judgment. Patients will be randomized to either the LCIG treatment group or the OMT group and follow 12-weeks of scheduled study visits. Subjects randomized to OMT will continue their current anti-PD medication regimen.
Results:
The primary efficacy outcome will be the mean change from baseline to week 12 in the Unified Dyskinesia Rating Scale (UDysRS) total score. Key secondary endpoints include “On” time without troublesome dyskinesia, the 8-item Parkinson’s Disease Questionnaire (PDQ-8), the Clinical Global Impression of Change assessment, the Unified Parkinson’s Disease Rating Scale (UPDRS) part II score, “Off” time, and UPDRS part III score. Adverse events will be monitored.
Conclusions:
Dyskinesia is difficult to treat and there is a lack of robust evidence for device-aided medical treatments in advanced PD patients. The current study is designed to determine whether LCIG is an effective management strategy for the treatment of dyskinesia in advanced PD patients.
To cite this abstract in AMA style:
A. Antonini, W. Poewe, D. Standaert, C. Zadikoff, S. Dubow, L. Bergmann, A. Yegin, C. Hall, W. Robieson, V. Felipe, L. Barbato. Effect of levodopa-carbidopa intestinal gel on dyskinesia: Design of an open-label, randomized multicenter 12-week study in advanced Parkinson’s disease patients [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/effect-of-levodopa-carbidopa-intestinal-gel-on-dyskinesia-design-of-an-open-label-randomized-multicenter-12-week-study-in-advanced-parkinsons-disease-patients/. Accessed June 15, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-levodopa-carbidopa-intestinal-gel-on-dyskinesia-design-of-an-open-label-randomized-multicenter-12-week-study-in-advanced-parkinsons-disease-patients/