Parkinson Disease
Conditions
Keywords
OFF episode
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.
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.
Interventions
DRUGApomorphine Cartridge
Staccato Cartridge
Sponsors
Peachtree BioResearch Solutions Inc.
DSG, Inc
ISS, Inc.
Alexza Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinded
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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. 3\. 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. 6\. Have a clinical diagnosis of PD; with fulfillment of Steps 1 and 2 of the UK Parkinson's Disease Brain Bank Criteria. 7\. 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. 8\. 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. 10\. 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. 11\. 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. 12\. 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.
Exclusion criteria
* Subjects eligible for enrollment in the study must meet all of the following inclusion criteria and none of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-Unified Parkinson's Disease Rating Scale | at 10, 20, 30 and 45 minutes | 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. |
Countries
United States
Outcome results
None listed