Session Information
Date: Tuesday, September 24, 2019
Session Title: Parkinsonisms and Parkinson-Plus
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: Analysis of dyskinesia as reported by PD diary, adverse events, UPDRS part IV dyskinesia score and examiner rated observation, during a phase 3 study of CVT-301 (levodopa inhalation powder) for the intermittent treatment of OFF periods in patients with Parkinson’s disease (PD) on a carbidopa/levodopa regimen.
Background: In a 12-week, randomized, double-blind, placebo-controlled study of 339 patients with PD experiencing OFF periods (SPAN-PD™), CVT-301 84 mg significantly improved motor function, measured by an improvement in UPDRS part III motor score pre-dose to 30 minutes post-dose at 12 weeks compared to placebo (LS mean change from baseline of -9.83 vs. -5.91 respectively; P=0.009). In addition, 58% of patients in the CVT-301 84-mg group turned ON and remained ON at the 60-minute assessment compared with 36% in the placebo group (P=0.003).
Method: Dyskinesia data were collected as: patient reported ON time with troublesome dyskinesia by PD diary for 3 consecutive days prior to each study visit, adverse events (AE) by standard reporting methods, UPDRS part IV dyskinesia score in clinic (questions 32-35), and examiner rated occurrence and severity (mild, moderate, or severe) of dyskinesia during the 60-minute post-dose period in the clinic.
Results: With an average usage of 2 doses per day, which remained consistent throughout the 12 weeks for both treatment groups, least squares (LS) mean change from baseline in patient diary-reported ON time with troublesome dyskinesia was 0.17h for CVT-301 84 mg and 0.17h for placebo at week 12. An AE of dyskinesia was reported by 4 (3.5%) patients in the CVT-301 84-mg group and none in the placebo group. No patient withdrew due to dyskinesia. UPDRS part IV dyskinesia average score at week 12 was 2.0 for 84 mg CVT-301 and 1.8 for placebo, representing changes from baseline of 0 and -0.2, respectively. Examiner rated dyskinesia during the 1-hour post-dose period was 16.7% in the 84-mg CVT-301 group and 8% in the placebo group at week 12; throughout the study, all were rated mild to moderate except 1 severe report in the placebo group.
Conclusion: In this phase 3 study of CVT-301, adverse events and examiner ratings of mild to moderate dyskinesia were reported more frequently for CVT-301 compared to placebo, but there was no increase in troublesome dyskinesia according to the patient reported diary and the overall impact on UPDRS part IV dyskinesia score was minimal.
To cite this abstract in AMA style:
E. Pourcher, A. Corbin, J. Qian, C. Kenney. Dyskinesia Rates in Patients with Parkinson’s Disease on CVT-301 (levodopa inhalation powder) [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/dyskinesia-rates-in-patients-with-parkinsons-disease-on-cvt-301-levodopa-inhalation-powder/. Accessed December 9, 2024.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/dyskinesia-rates-in-patients-with-parkinsons-disease-on-cvt-301-levodopa-inhalation-powder/