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 |
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.
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
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