Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes

The purpose of this protocol is to establish the safety, tolerability, and efficacy of AZ-009 compared to placebo in patients with established PD experiencing daily OFF episodes.

Patients between the ages of 30 and 85 with a clinical diagnosis of established PD who experience motor fluctuation and have recognizable OFF periods are eligible for participation in this study. The patients will be classified as Modified Hoehn \& Yahr stage II-IV in the ON state and have clear, self-described daily motor fluctuations while on oral l-dopa or Carbidopa (with or without adjunctive PD therapy).

This study will be conducted in approximately 50 patients, with up to 8 Open-Label titration in-clinic visits with treatment at home between visits. This is followed by Double Blind which includes a 13 day treatment at home period, and an in-clinic visit and an End of Study/Early Termination visit for each patient with established Parkinson's disease (PD) experiencing daily OFF episodes.