Objective: Post-hoc analysis of subjects with Parkinson’s disease (PD) achieving > 30% reduction in UPDRS motor score (UPDRSIII) from pre- to post-dose over the first hour of treatment with placebo or CVT-301, a levodopa inhalation powder in development for the treatment of OFF periods.

Background: In a 12-week, randomized, double-blind, placebo-controlled study of 339 subjects experiencing OFF periods, CVT-301 84mg significantly improved motor function, measured by an improvement in UPDRSIII score pre-dose to 30 minutes post-dose at 12 weeks. In addition 57.7% of subjects in the CVT-301 84mg group turned ON within 60 minutes and maintained ON through the 60 minute assessment compared with 36.1% in the placebo group (p=0.003). Reduction of >30% in UPDRSIII has been used previously as a marker of improvement in response to levodopa and other treatments.

Methods: UPDRSIII score was measured at 10, 20, 30 and 60 minutes post-dose with CVT-301 60mg and 84mg vs placebo. Post-hoc analysis evaluated the percent of subjects with > 30% reduction in total UPDRSIII score pre- to post-dose within the first hour. The percentage of subjects in the CVT-301 60mg and 84mg groups who achieved > 30% reduction in total UPDRSIII score at each of the assessment time points, and the average across all time points, were compared to placebo. Other analyses were also conducted.

Results: Significant findings at 12 weeks included a greater percentage of CVT-301 treated subjects achieving a > 30% reduction in UPDRSIII compared to placebo at 30 minutes (52% for CVT-301 84mg, p=0.015; 53% for CVT-301 60 mg, p=0.011; 35% for placebo). 27% of CVT-301 84mg subjects achieved > 30% reduction in UPDRSIII at 10 min, which was significantly greater compared to 14% in the placebo group (p=0.019); the 60mg group did not achieve significance (24%, p=0.08). Averaged across all time points, the percentage of CVT-301 treated subjects with > 30% reduction in UPDRSIII was greater than placebo (45% for CVT-301 84mg, p=0.02; 45% for CVT-301 60mg, p=0.02; 29% for placebo).

Conclusions: In this Phase 3 study a greater proportion of CVT-301 treated subjects had clinically relevant improvements in their motor function by achieving >30% reduction in UPDRSIII compared to placebo. These observations further support the efficacy of CVT-301 in treatment of OFF periods.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-cvt-301-levodopa-inhalation-powder-for-treatment-of-off-periods-in-parkinsons-disease/