This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Civitas Investigational Site 1013
Little Rock, Arkansas, United States
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Time frame: pre-dose to 60 minutes following treatment
Time to resolution of OFF episode to an ON state.
Time frame: 28 days duration outpatient treatment
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry
Time frame: change from baseline through 28 days outpatient use
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Civitas Investigational Site 1004
Boca Raton, Florida, United States
Civitas Investigational Site 1002
Port Charlotte, Florida, United States
Civitas Investigational Site 1015
Tampa, Florida, United States
Civitas Investigational Site 1007
Kansas City, Kansas, United States
Civitas Investigational Site 1010
Boston, Massachusetts, United States
Civitas Investigational Site 1001
Bingham Farms, Michigan, United States
Civitas Investigational Site 1008
Roseville, Michigan, United States
Civitas Investigational Site 1009
Saint Louis, Michigan, United States
Civitas Investigational Site 1005
West Bloomfield, Michigan, United States
...and 12 more locations