Category: Parkinson’s Disease: Clinical Trials
Objective: This study evaluated the effectiveness of LCIG versus optimized medical treatment (OMT) on the duration and severity of dyskinesia in aPD patients.
Background: Approximately 40% of advanced Parkinson’s disease (aPD) patients present with troublesome dyskinesia symptoms after about 4 years of oral levodopa treatment. Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) has been shown to improve motor complications including dyskinesia, but comparative data are limited.
Method: This phase 3b, open-label, randomized, multicenter, 12-week, interventional study evaluated LCIG naïve aPD patients (≥30 on the Unified Dyskinesia Rating Scale [UDysRS]) randomized to LCIG or OMT treatment groups (NCT02799381). The primary endpoint was the mean change from baseline (BL) to Week (W) 12 in UDysRS total scores analyzed using a mixed-effects, repeated-measures model. Adverse events (AEs) were also monitored.
Results: Baseline demographics and disease characteristics are presented in Table 1. The primary endpoint of mean change from BL in dyskinesia as measured by the UDysRS was significantly improved in the LCIG group (n=24; -17.4 ± 2.8) compared to OMT (n=26; -2.3 ± 2.6) at W12 (-15.1, 95% CI, -21.5 to -8.6; p<.001). Improvement in dyskinesia occurred after two weeks of treatment and was sustained throughout the study. Overall, treatment-emergent AEs (TEAEs) were reported in 27 patients (44.3%), 18 (64.3%) patients treated with LCIG and 9 (27.3%) patients treated with OMT. Serious AEs occurred in 2 (7.1%) patients treated with LCIG.
Conclusion: LCIG significantly improved dyskinesia compared to OMT supporting LCIG as an effective treatment of dyskinesia in aPD patients. The observed safety events in this study were in line with the established LCIG safety profile.
Abstract previously submitted to EAN (2020) European Academy of Neurology – 6th Congress, disposition pending.
To cite this abstract in AMA style:
E.F Alvarez, C. Spanaki, E. Pekkonen, L. Manzanares, Y. Liu, O. Sánchez-Soliño, L. Barbato. Effect of Levodopa-Carbidopa Intestinal Gel Versus Optimized Medical Treatment on Dyskinesia in Advanced Parkinson’s Disease Patients: Final Results of the Randomized 12-Week DYSCOVER Study [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/effect-of-levodopa-carbidopa-intestinal-gel-versus-optimized-medical-treatment-on-dyskinesia-in-advanced-parkinsons-disease-patients-final-results-of-the-randomized-12-week-dyscover-study/. Accessed November 21, 2024.« Back to MDS Virtual Congress 2020
MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-levodopa-carbidopa-intestinal-gel-versus-optimized-medical-treatment-on-dyskinesia-in-advanced-parkinsons-disease-patients-final-results-of-the-randomized-12-week-dyscover-study/