Assess the effectiveness of levodopa-carbidopa intestinal gel (LCIG) on motor fluctuations and dyskinesias in advanced Parkinson’s disease (PD) patients treated in routine clinical practice.

DUOGLOBE is the first multinational observational study of LCIG in routine care, including US sites, with 3-years follow-up. The primary outcome is mean change in patient-reported “Off” time; secondary outcomes include dyskinesia duration and severity, as measured by the recently developed Unified Dyskinesia Rating Scale (UDysRS). Outcomes were collected at baseline, and at scheduled visits closest to months (M) 3, 6, and 12 (± 14 days) in this interim analysis.

139 patients are included in this interim analysis (78% ≥65 years old; 51% ≥10 years’ disease duration), and sample sizes became limited over time due to patients not yet achieving later visits. LCIG treatment significantly reduced patient-reported “Off” time (mean decrease from baseline to M12: -4.1 hours) irrespective of sex, age, and disease duration. Dyskinesia assessed by UDysRS significantly improved and was maintained through M12 (mean decrease from baseline: -12.7). Improvements according to UPDRS part IV scores for duration of “Off” time (through M12), dyskinesia duration (through M6), dyskinesia-related disability (through M12), and dyskinesia-related pain (through M12) were also observed. Safety was consistent with LCIG’s known profile.

This interim analysis confirms the improvement in “Off” time with LCIG in routine clinical practice. This first analysis using UDysRS, and supporting data from UPDRS part IV, showed that LCIG treatment was also associated with a reduction in dyskinesia duration and severity. These findings provide further evidence for the real-world effectiveness of LCIG on motor fluctuations and duration and severity of dyskinesia.