This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).
An "OFF state" is defined as the time when medication is no longer providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)
All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)
Site #9015
Fountain Valley, California, United States
Site #9002
Boca Raton, Florida, United States
Site #9017
Hallandale, Florida, United States
Site #9008
Number of patients with Adverse Events (AEs) including Serious AEs
Time frame: up to 9 days
Examiner rated time to ON comparisons between treatments (CVT-301 and placebo)
An "ON state" is defined as the time when medication is providing benefit with respect to mobility, slowness, and stiffness, and may or may not be providing complete alleviation of all PD symptoms.
Time frame: day 1 and day 3
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St. Petersburg, Florida, United States
Site #9018
Sunrise, Florida, United States
Site #9004
Tampa, Florida, United States
Site #9016
Atlanta, Georgia, United States
Site #9009
Chicago, Illinois, United States
Site #9003
Farmington Hills, Michigan, United States
Site #9005
West Bloomfield, Michigan, United States
...and 1 more locations