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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT05979415

Run by

Alexza Pharmaceuticals, Inc.

People needed

8

Starts

2023-09-27

Expected to finish

2024-02-28

Last updated by the study team

2025-10-21

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 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:
• Oral contraceptive medications; Intra uterine devices; Hormonal implants; Injectable contraceptive medications; Double-barrier methods 14. Male subjects must practice true abstinence from heterosexual contact or, during sexual contact with a pregnant female or a female of childbearing potential, agree to use a condom or have had vasectomy with negative semen analysis and refrain from sperm donation during the duration of the study and up to 90 days after last dose of study drug.

You may not qualify if…

• Subjects eligible for enrollment in the study must meet all of the following inclusion criteria and none of the exclusion criteria.
• Inclusion Criteria:
• 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
• 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:
• Oral contraceptive medications; Intra uterine devices; Hormonal implants; Injectable contraceptive medications; Double-barrier methods
• Male subjects must practice true abstinence from heterosexual contact or, during sexual contact with a pregnant female or a female of childbearing potential, agree to use a condom or have had vasectomy with negative semen analysis and refrain from sperm donation during the duration of the study and up to 90 days after last dose of study drug.
• Exclusion Criteria:
• Previous significant complications from oral dopamine agonist therapy including hospitalization, hallucinations, or any other clinically relevant neuropsychiatric adverse event. Known intolerance to apomorphine.

Where it is running

• Movement Disorders Center of Arizona — Scottsdale, Arizona, United States
• Tuscon Neuroscience Research (M3 Wake Research) — Tucson, Arizona, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Cenexel Rocky Mountain Clinical Research — Englewood, Colorado, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Holy Cross Health — Fort Lauderdale, Florida, United States
• Visionary Investigators Network — Miami, Florida, United States
• Parkinson's Disease Treatment Center of Southwest Florida — Port Charlotte, Florida, United States
• CenExel iResearch Atlanta (Decatur) — Decatur, Georgia, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• Accellacare of Piedmont Healthcare — Statesville, North Carolina, United States
• KCA Neurology, (Part of Ki Health Partners, LLC) — Franklin, Tennessee, United States
• Lone Star Neurology, (Part of Ki Health Partners, LLC) — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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