Trial · NCT04157933
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
NCT04157933, Phase 1, Completed, Alexza Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease. Trials, record NCT04157933. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04157933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
- NCT number
- NCT04157933
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Conditions
- Parkinson's Disease
- Interventions
- 009-A1, 009-A2, 009-A3, 009-A0, 009-B1 (active --> placebo) crossover, 009-B2 (placebo --> active) crossover
- First posted
- 2019-11-08
- Last updated
- 2020-11-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC | 6 days | Dose proportionality of inhaled Staccato apomorphine AUC across all 3 doses during Days 1-5 and multiple daily dosing (all 3 doses q 2 hr per day) on Day 6 using a power model \[regression of log(AUC) versus log(dose)\] in subjects with established Parkinson's disease |
| Primary | B1 - Effect on MDS-UPDRS in Parkinson's disease OFF periods | 2 days | Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in subjects with established Parkinson's disease experiencing regular OFF episodes. |
| Primary | B2 - Effect on Physician Disease State Assessment in Parkinson's disease OFF periods | 2 days | Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Physician Disease State Assessment in subjects with established Parkinson's disease experiencing regular OFF episodes. |
| Primary | B3 - Effect on Patient Assessment of ON/OFF in Parkinson's disease OFF periods | 2 days | Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on Patient Assessment of ON/OFF in subjects with established Parkinson's disease experiencing regular OFF episodes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04157933
GET https://conductscience.org/api/trials/v1/NCT04157933/registered