Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Clinical Trial Investigator:Danny Bega, MD
This study is a randomized, double-blind, placebo-controlled, multicenter study of inhaled CVT-301 or placebo for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). Approximately 345 patients will be randomized in a 1:1:1 ratio to receive inhaled CVT-301 DL1, CVT-301 DL2, or placebo. The Primary Objective is to compare the effects of the study drug on the mean change from pre-dose in average Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 motor score at 10 to 60 minutes following treatment of patients experiencing an OFF episode at Treatment Visit 3 (TV3) (Week 8) and Treatment Visit 4 (TV4) (Week 12).
Clinical Trial Eligibility Criteria:
- Hoehn & Yahr 1-3, 30-80 years old
- Experience motor fluctuations (min of 2 hrs off time per day)
- Stable on LD-therapy, include doses at least 4 times a day and a total of </=1600mg LD-containing medications
- No history of chronic respiratory disease within the last 5 years
Study Visits: Eight visits
Compensation: Parking voucher for designated parking garages
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