Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event
Study Overview
Brief Summary
Real-World Participants Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease
Detailed Description
This observational study includes an Enrollment Day (participants enrolled any time between their prescription for the infusion and ONAPGO initiation); a Baseline Period (prior to ONAPGO initiation which includes in-home education on the use of ONAPGO by the Clinical Nurse Navigator [CNN] according to standard practice for patients with PD-prescribed ONAPGO); Dose Initiation, Titration, and Optimization per Prescription Periods; a Maintenance Period; Maintenance CNN standard of care visits; and an End-of-Study (EOS)/Discontinuation Visit.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event
Time Frame: Approximately 52-60 weeks
Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant
Titration Duration and Time to Optimized Dose
Time Frame: Approximately 52-60 weeks
The time from the date of ONAPGO™ initiation to the date of Dose Optimization Confirmation, as documented by the HCP/Investigator Unit of Measure: days
Concomitant Parkinson's Disease (PD) Medication Adjustments
Time Frame: Approximately 52-60 week
Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. "Percentage of participants"
Secondary Outcomes
- Perception of Patient Global Health Improvement(Approximately 52-60 weeks)
- Caregiver Burden(Approximately 52-60 weeks)
- HCP/Investigator burden for ONAPGO providers(Approximately 52-60 weeks)
- Evaluation of ONAPGO usage during the maintenance period(Approximately 52-60 weeks)
- Safety by monitoring adverse events (AEs)(Approximately 52-60 weeks)