Trials / Terminated
TerminatedNCT05979415
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
A Randomized, Double-Blind, to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Alexza Pharmaceuticals, Inc. · Unknown
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted with In-clinic visits and treatment at home for each patient with established Parkinson's disease (PD) experiencing daily OFF episodes.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apomorphine Cartridge | Staccato Cartridge |
Timeline
- Start date
- 2023-09-27
- Primary completion
- 2024-02-28
- Completion
- 2024-02-28
- First posted
- 2023-08-07
- Last updated
- 2025-10-21
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05979415. Inclusion in this directory is not an endorsement.