Northwestern University Feinberg School of Medicine

Parkinson's Disease and Movement Disorders Center

Efficacy and Safety of CVT-301 in Parkinson’s Disease Patients With Motor Response Fluctuations

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:

Study Visits: Eight visits

Compensation: Parking voucher for designated parking garages

For More Information: Call us at 312-503-0755, or email pdclinicaltrials@northwestern.edu.