Objective: To report patient experiences from a clinical trial investigating Parkinson’s disease (PD) control following treatment with inhaled levodopa.

Background: CVT-301, an inhaled levodopa powder formulation, is under investigation for treatment of OFF episodes in PD patients. Data from a Phase 2b study of CVT-301 showed improvement in motor function and in daily OFF time. Patient Global Impression of Change (PGI-C), a patient-reported outcome, was included in this study.

Methods: This was a randomized, double-blind, placebo-controlled study in PD patients experiencing >2hours/day OFF time. CVT-301 or placebo was used for 4 weeks as an adjunct to usual PD medications for OFF symptoms. Two doses were studied (35 mg [dosing level 1 (DL1), weeks 1–2]; 50 mg [dosing level 2 (DL2), weeks 3–4]). PGI-C ratings were measured at DL1 (end of week 2) and DL2 (end of week 4) to assess the effect of CVT-301 on patient impression of Parkinsonian control. PGI-C ratings were compared between placebo and CVT-301 using chi-square test. PGI-C ratings per baseline demographics and clinical characteristics were explored. Safety and tolerability were assessed.

Results: Eighty-six patients with PD were randomized 1:1 to CVT-301 or placebo. Seventy-nine and 74 patients completed the PGI-C at DL1 and DL2, respectively. The majority of patients reported an improved impression of Parkinsonian control with CVT-301 (DL1:65.0%; DL2:71.8%), whereas fewer than half reported improvements with placebo (DL1:43.6%; DL2:45.7%). Compared with placebo, treatment with CVT-301 was associated with a significantly favorable impression of PD at DL2 (71.8%vs45.7%, P=0.0225) and a directional favorable impression (65.0%vs43.6%, P=0.0561) at DL1. Baseline demographic and clinical characteristics did not impact PGI-C ratings. CVT-301 was generally tolerated during the 4-week trial.

Conclusions: Most patients reported an improved PGI-C rating with CVT-301 as an adjunctive treatment, supporting other positive findings regarding improvements of motor function and daily OFF time.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/patient-experiences-following-parkinsons-disease-treatment-with-inhaled-levodopa-results-from-a-phase-2b-study/