Abstract
Introduction This study assesses correlations of ‘On’ time without troublesome dyskinesia (TSD) and dyskinesia with health-related quality of life (HRQoL), activities of daily living (ADL), and Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) among patients with advanced Parkinson’s disease (aPD).
Methods In the phase 3b, multicenter, randomized, open-label DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) study (NCT02799381), patients with levodopa-responsive aPD and a Unified Dyskinesia Rating Scale (UDysRS) Total Score ≥30 received 12 weeks of optimized medical treatment or levodopa-carbidopa intestinal gel (randomized 1:1). This post hoc analysis combines data from both groups using Pearson correlation coefficients for baseline and change to week 12.
Results Among patients (n=60), there were significant moderate positive correlations between UDysRS and HRQoL (8-item Parkinson’s Disease Questionnaire [PDQ-8]), ADL (Unified Parkinson’s Disease Rating Scale part II [UPDRS II]), CGI-S (baseline), and CGI-C (week 12) at baseline and for change to week 12. There were significant moderate negative correlations between changes to week 12 in ‘On’ time without TSD and PDQ-8, UPDRS II, and CGI-C, and a weak negative correlation with PDQ-8 at baseline. Baseline ‘On’ time without TSD was not correlated with baseline UPDRS II or CGI-S. All change from baseline correlations were stronger than baseline correlations. Safety was consistent with the established LCIG safety profile, as reported previously.
Conclusion Dyskinesia signs/symptoms were moderately correlated with ADL, HRQoL, and CGI, while ‘On’ time without TSD was mostly negatively correlated, indicating a relevant impact on patients with high dyskinesia burden.
