Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of
CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor
fluctuations (OFF episodes). All patients will receive active treatment, but patients will be
blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study
for those patients who participated in that study and remain eligible for this study. In
addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009
(NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as
CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.