Diego Santos García, María Cerdán Sánchez, Rosa Yáñez Baña, Iria Cabo, Maria Icíar Cimas Hernando
HRQoL and NMS associated with OFF episodes improved in PwP after 12 weeks using CVT-301.
BACKGROUND: CVT-301 (Inbrija) has demonstrated its effectiveness in treating OFF periods in people with Parkinson's disease (PwP). However, its effect on non-motor symptoms (NMS) and quality of life has not been researched yet. Our aim was to analyze the change observed in health-related quality of life (HRQoL) and, as a secondary exploratory analysis, NMS associated with OFF episodes in PwP treated with CVT-301.
METHODS: INLEVO-LIFE PD (an open-label study of the effect of INhaled LEVOdopa on quality of LIFE and non-motor symptoms in Parkinson's Disease) is a prospective open-label study conducted in five centers in Spain. The change from baseline (V0) to the end of the observational period (12 ± 2 weeks) (V12w) in the 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39) total score was the primary efficacy measure.
RESULTS: Forty PD patients (age 62.3 ± 9.2 years; 55% males) were included between March/2024 and November/2025. At 12 weeks, 34 patients were using CVT-301 and completed the follow-up (85%). The PDQ39 total score decreased from 43.6 ± 24.2 at V0 to 31.4 ± 20.6 at V12w (p < 0.0001). A significant decrease was observed in the mean score of 4 domains of the PDQ39. NMS burden was reduced at v12w from the OFF state to 30, 60, and 90 min after using CVT-301 (p < 0.0001). Mean daily OFF time decreased by 1.6 ± 1.9 h (p < 0.0001). Adverse events related to CVT-301 were reported in 35% of the patients.
CONCLUSION: HRQoL and NMS associated with OFF episodes improved in PwP after 12 weeks using CVT-301.