Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

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 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 ;

Exclusion Criteria:

- 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.