Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 80
Updated:8/10/2018
Start Date:April 2013
End Date:January 2014

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A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

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.


Inclusion Criteria:

- Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;

- Hoehn and Yahr Stage 1-3 in an "on" state;

- Require levodopa-containing medication regimen at least 4 times during the waking day;

- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
per waking day (excluding early morning "off" time) and demonstrate levodopa
responsiveness;

- Are on stable PD medication regimen.

Exclusion Criteria:

- Pregnant or lactating females;

- Previous surgery for PD or plan to have stereotactic surgery during the study period;

- History of psychotic symptoms requiring treatment, or suicide ideation or attempt
within last year;

- Adequate lung function as measured by spirometry;

- Any significant condition, severe concurrent disease, abnormality or finding that
would make patients unsuitable or may compromise patient safety.
We found this trial at
14
sites
Port Charlotte, Florida
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Port Charlotte, FL
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Bingham Farms, Michigan
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Bingham Farms, MI
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Boca Raton, Florida
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Boca Raton, FL
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Boston, Massachusetts
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Boston, MA
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Cassino,
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Cleveland, OH
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Kansas City, Kansas
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Kansas City, KS
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Kingston, New York 12401
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Kingston, NY
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Kirkland, Washington
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Kirkland, WA
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Little Rock, Arkansas
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Little Rock, AR
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Roseville, Michigan
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Roseville, MI
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Saint Louis, Michigan 48880
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Saint Louis, MI
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Tampa, FL
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West Bloomfield, Michigan
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West Bloomfield, MI
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