Objective: The DYSCOVER study will be the first interventional, randomized study to evaluate the comparative effectiveness of levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on the duration and severity of dyskinesia in advanced PD patients.

Background: Dyskinesias are among the most troublesome symptoms of advanced PD with approximately 40% of patients presenting dyskinesia after about 4 years of levodopa treatment. [1] Interventional and observational studies suggest that LCIG decreases duration and severity of off-time, off-dystonia, and dyskinesia [2], but comparative data on dyskinesia are limited.

Method: Sixty LCIG-naïve advanced PD patients with severe motor fluctuations and dyskinesia despite optimal medical treatment will be enrolled at approximately 30 movement disorder centers in accordance with local product label. Patients will be randomized (LCIG treatment group or OMT group) for 12-weeks of treatment with scheduled study visits at Day 1 and Weeks 2, 4, 8, and 12. Patients randomized to OMT will continue their optimal anti-PD medication regimen. The primary efficacy outcome will be the effect of LCIG on dyskinesia as measured by Unified Dyskinesia Rating Scale (UDysRS) total score. A key secondary objective is to assess the efficacy of LCIG, relative to that of OMT, on dyskinesia as measured by PD diaries and health-related quality of life assessments. Adverse events will be monitored.

Results: As of January 2019, 38 patients have been enrolled in the study. Baseline demographics and disease characteristics for these patients are presented in Table 1. [table1]

Conclusion: Robust comparative evidence is lacking for the use of LCIG for the management of dyskinesia in advanced PD. This study is designed to evaluate whether LCIG is an effective management strategy for the treatment of dyskinesia in advanced PD patients.

References: 1. Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disorder 2001; 16:448-58. 2. Olanow et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson’s disease: a randomized, controlled, double-blind, double-dummy study. Lancet Neurol. 2014; 13(2):141-9.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/the-effect-of-levodopa-carbidopa-intestinal-gel-relative-to-optimized-medical-treatment-on-dyskinesia-design-and-baseline-characteristics-for-an-open-label-randomized-multicenter-12-week-study-in-ad/