A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Description
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion 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 3 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;
- Total daily levodopa (LD) dose <1600 mg/day;
- Able to perform a spirometry maneuver in the ON and OFF states
- Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;
- Pregnant or lactating females;
- Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
- History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
- Known contraindication to the use of levodopa;
- Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
- Any any contraindication to performing routine spirometry.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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