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

NCT05979415 | Terminated Phase 2 FDA Drug

• 1 other identifier: AMDC 009-201
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Parkinson Disease

Keywords

OFF episode

Outcome Measures

Primary Outcomes (1)

• MDS-Unified Parkinson's Disease Rating Scale

  The MDS-UPDRS is a revision of the Unified Parkinson's Disease Rating Scale (UPDRS) and was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications.

  at 10, 20, 30 and 45 minutes

Study Arms (2)

Staccato Apomorphine

ACTIVE COMPARATOR

1mg, 2mg, 3mg, 4mg

Drug: Apomorphine Cartridge

Staccato Placebo

PLACEBO COMPARATOR

Placebo

Drug: Apomorphine Cartridge

Interventions

Apomorphine Cartridge DRUG

Staccato Cartridge

Also known as: placebo

Staccato Apomorphine; Staccato Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• \. Willing and able to travel to the clinical research center and adhere to the overall study visit schedule, procedures, and other protocol requirements.
• \. Male or female between the ages of 30 and 85 (inclusive). 4. Body weight ≥ 50 kg. 5. Willing to abstain from alcohol for 6 hours prior to a study visit and minimize alcohol use throughout the study duration.
• \. Have a clinical diagnosis of PD; with fulfillment of Steps 1 and 2 of the UK Parkinson's Disease Brain Bank Criteria.
• \. Optimized and stabilized on oral dopaminergic therapy including levodopa at least 3 times daily and in combination with decarboxylase inhibitor at least 30 days prior to screening.
• \. Classified as Modified Hoehn \& Yahr stage II-IV in the ON state at Visit 1. 9. Have an MDS-UPDRS III score of at least 30 in the OFF state prior to the L-dopa challenge at Visit 2.
• \. Experience self-described motor fluctuations (confirmed by the Motor Fluctuation Questionnaire at Screening) with recognizable OFF periods while on optimized oral l-dopa or dopamine agonist therapy.
• \. Experience at least 2 hours of OFF time per day and show responsiveness to levodopa (defined by a ≥ 30% reduction in MDS-UPDRS III score compared to pre-dose) at Visit 2.
• \. Female subjects, who are not pregnant or breastfeeding, and one of the following conditions applies: 13. Surgically sterile (including bilateral tubal ligation) for at least 3 months prior to screening.
• Postmenopausal, defined as 1 of the following:
• Last menstrual sequence greater than 12 months prior to screening
• Last menstrual sequence greater than 6 months prior to screening and a serum follicle-stimulating hormone (FSH) concentration \> 40 mIU/mL
• Of childbearing potential (i.e., do not meet the criteria outlined above), patient must:
• Have a negative urine pregnancy test at Screening and Day -1, as verified by the study doctor prior to starting study therapy.
• Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption with one of the following methods during the study participation up until 30 days after administration of study drug:

You may not qualify if:

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• Willing and able to travel to the clinical research center and adhere to the overall study visit schedule, procedures, and other protocol requirements.
• Male or female between the ages of 30 and 85 (inclusive).
• Body weight ≥ 50 kg.
• Willing to abstain from alcohol for 6 hours prior to a study visit and minimize alcohol use throughout the study duration.
• Have a clinical diagnosis of PD; with fulfillment of Steps 1 and 2 of the UK Parkinson's Disease Brain Bank Criteria.
• Optimized and stabilized on oral dopaminergic therapy including levodopa at least 3 times daily and in combination with decarboxylase inhibitor at least 30 days prior to screening.
• Classified as Modified Hoehn \& Yahr stage II-IV in the ON state at Visit 1.
• Have an MDS-UPDRS III score of at least 30 in the OFF state prior to the L-dopa challenge at Visit 2.
• Experience self-described motor fluctuations (confirmed by the Motor Fluctuation Questionnaire at Screening) with recognizable OFF periods while on optimized oral l-dopa or dopamine agonist therapy.
• Experience at least 2 hours of OFF time per day and show responsiveness to levodopa (defined by a ≥ 30% reduction in MDS-UPDRS III score compared to pre-dose) at Visit 2.
• Female subjects, who are not pregnant or breastfeeding, and one of the following conditions applies:
• Surgically sterile (including bilateral tubal ligation) for at least 3 months prior to screening.
• Postmenopausal, defined as 1 of the following:
• Last menstrual sequence greater than 12 months prior to screening

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead
• Peachtree BioResearch Solutions Inc.: collaborator
• DSG, Inc: collaborator
• ISS, Inc.: collaborator

Study Sites (13)

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Tuscon Neuroscience Research (M3 Wake Research)

Tucson, Arizona, 85710, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

Cenexel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Holy Cross Health

Fort Lauderdale, Florida, 33308, United States

Location

Visionary Investigators Network

Miami, Florida, 33133, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, 33980, United States

Location

CenExel iResearch Atlanta (Decatur)

Decatur, Georgia, 30030, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28265, United States

Location

KCA Neurology, (Part of Ki Health Partners, LLC)

Franklin, Tennessee, 37067, United States

Location

Lone Star Neurology, (Part of Ki Health Partners, LLC)

Frisco, Texas, 75035, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: September 27, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: October 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)