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

Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.

Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed

Time frame: at week 12

UPDRS Part III Motor Score at 20 Minutes

Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

Time frame: at week 12

Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12

Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.

Time frame: week 12

UPDRS Part III at 10 Min.

Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

Time frame: week 12