Apomorphine Infusion Experiences in Parkinson's Disease
Data Collection
Collected from today forward - ProspectiveSynucleinopathies+6
+ Basal Ganglia Diseases
+ Brain Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 31, 2025
Actual date on which the first participant was enrolled.This study is focused on understanding the real-world experiences of patients in the United States using a treatment called ONAPGO, which is a continuous subcutaneous apomorphine infusion, specifically designed for individuals with Parkinson's Disease. Parkinson's Disease is a condition that affects movement and can cause tremors, stiffness, and other symptoms. The study aims to gather insights into how patients manage their symptoms using ONAPGO in everyday life. This information is crucial because it helps healthcare providers better understand the practical aspects of using this treatment and can lead to improved care strategies for those living with Parkinson's Disease. Participants in the study go through several stages, starting with an Enrollment Day when they first receive their prescription for ONAPGO. Before starting the infusion, there is a Baseline Period where patients receive in-home education from a Clinical Nurse Navigator on how to use ONAPGO properly. The study involves different phases, including starting the dose, adjusting it as needed, and maintaining the treatment. Throughout the study, participants receive regular care visits from their nurse to ensure proper management of the treatment. At the end of the study, or if they decide to stop the treatment, participants have a final visit to review their experiences. The study does not involve any interventions beyond standard care, and it focuses on observing how the treatment fits into the daily lives of those with Parkinson's Disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Participant has received a prescription for ONAPGO™ according to the standard of care. Participant has opted into receiving support services from the Clinical Nurse Navigator (CNN), a registered nurse specially trained to work with persons with Parkinson's disease, as noted on the Prescription Enrollment Form. The HCP/Investigator determines the participant is an appropriate study participant. Participant is able and willing to provide informed consent (or informed assent form \[IAF\], as applicable) and signs the consent form on the Enrollment Day. Exclusion Criteria: Did not receive a prescription for ONAPGO™. Prescribed ONAPGO™, but the HCP/Investigator determines the participant should not participate in this observational study. Concomitant use of ONAPGO™ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron. Known hypersensitivity to apomorphine or to excipients of ONAPGO™, including sulfite (e.g., sodium metabisulfite).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Parkinson's Disease and Movement Disorders Center - Orange County (South)
Aliso Viejo, United StatesOpen Parkinson's Disease and Movement Disorders Center - Orange County (South) in Google MapsParkinson's Disease and Movement Disorders Center - Orange County (North)
Irvine, United StatesParkinson's Research Centers of America - Palo Alto
Palo Alto, United StatesParkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, United States