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Dopamine Agonist

Staccato Apomorphine for Parkinson's Disease

Phase 2
Recruiting
Research Sponsored by Alexza Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
2. Willing and able to travel to the clinical research center and adhere to the overall study visit schedule, procedures, and other protocol requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 10, 20, 30 and 45 minutes
Awards & highlights

Study Summary

This trial will involve both in-clinic visits and at-home treatment for patients who have been diagnosed with Parkinson's disease and are experiencing daily OFF episodes.

Who is the study for?
This trial is for people aged 30-85 with Parkinson's Disease who have daily OFF episodes despite optimized oral dopaminergic therapy. They must recognize their OFF periods, experience at least 2 hours of OFF time per day, and respond to levodopa. Participants should be able to visit the clinic, follow the study plan, weigh over 50 kg (110 lbs), not drink alcohol before visits, and meet certain health criteria.Check my eligibility
What is being tested?
The trial tests Staccato Apomorphine (AZ-009) in patients with Parkinson's experiencing OFF episodes. It involves in-clinic assessments and home treatment. The goal is to see if this medication can safely reduce these episodes when standard treatments aren't enough.See study design
What are the potential side effects?
While specific side effects are not listed here, apomorphine-related side effects generally include nausea, drowsiness or sleepiness, dizziness upon standing up due to low blood pressure (orthostatic hypotension), yawning excessively, runny nose or congestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must comprehend and willingly sign a knowledgeable consent form before any research-related assessments/procedures take place.
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I can travel to the study site and follow the study schedule and requirements.
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My Parkinson's is at stage II-IV and my symptoms worsen without medication.
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I experience changes in my movement control despite taking my Parkinson's medication.
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I have at least 2 hours of worsened symptoms daily but improve with levodopa.
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I am a woman not pregnant or breastfeeding and am surgically sterile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 10, 20, 30 and 45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10, 20, 30 and 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MDS-Unified Parkinson's Disease Rating Scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Staccato ApomorphineActive Control1 Intervention
1mg, 2mg, 3mg, 4mg
Group II: Staccato PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

PeachTreeUNKNOWN
DSG-USUNKNOWN
DSGUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on the number of participants enrolled in this medical study?

"To successfully conduct this study, a total of 50 eligible participants are required. The trial will be overseen by Alexza Pharmaceuticals, Inc., and conducted at multiple research sites including Tuscon Neuroscience Research (M3 Wake Research) in Tucson, California, as well as The Parkinson's and Movement Disorder Institute in Fountain Valley, Colorado."

Answered by AI

Is the age cutoff for participants in this study set at 45 years or older?

"To be considered for this clinical trial, potential participants must fall within the age range of 30 to 85 years. It is worth noting that there are a total of 21 studies available specifically for patients under the age of 18, while an extensive number of 487 studies cater to individuals over the age of 65."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for the use of Staccato Apomorphine?

"Based on our team's assessment at Power, the safety rating for Staccato Apomorphine is 2 since this trial falls under Phase 2. Although there is some available data supporting safety, no evidence regarding efficacy has been established yet."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"This clinical trial is being conducted at multiple locations, including Tuscon Neuroscience Research (M3 Wake Research) in Tucson, California; The Parkinson's and Movement Disorder Institute in Fountain Valley, Colorado; Cenexel Rocky Mountain Clinical Research in Englewood, Florida. Additionally, there are 13 more locations where the study is taking place."

Answered by AI

Is this clinical trial currently accepting new participants?

"Indeed, the information provided on clinicaltrials.gov confirms that this particular clinical trial is currently in the process of recruiting patients. The initial posting took place on September 27th, 2023 and it was last updated on January 3rd, 2024. The study aims to enroll a total of 50 participants distributed among 13 different locations."

Answered by AI

Who else is applying?

What site did they apply to?
KCA Neurology, (Part of Ki Health Partners, LLC)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
2023. "Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979415.
All > Tucson
~32 spots leftby Apr 2025
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