Parkinson Disease
Conditions
Keywords
ONAPGO
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.
Interventions
OTHERObservational study
Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titration Duration and Time to Optimized Dose | 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 | Approximately 52-60 week | Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. Percentage of participants |
| The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event | Approximately 52-60 weeks | Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ONAPGO usage during the maintenance period | Approximately 52-60 weeks | Hourly modal infusion rate (mg/hour) during the maintenance period Daily modal dose (mg/day) during the maintenance period Daily modal duration (hour) during the maintenance period |
| Perception of Patient Global Health Improvement | Approximately 52-60 weeks | Change from baseline in the Patient Global Impression of Change (PGI-C) scale, with scores ranging from 1 (very much improved) to 7 (very much worse); lower scores indicate better outcomes. Unit of Measure: PGI-C score (range 1-7) |
| Safety by monitoring adverse events (AEs) | Approximately 52-60 weeks | Safety is measured by AE evaluation according to the standard of care and the percentage of participants who discontinue ONAPGO™ treatment due to AEs |
| Caregiver Burden | Approximately 52-60 weeks | Change from baseline in caregiver quality of life (QoL) as determined by scores on the European Quality of Life 5 Dimensions (EQ-5D) scale. This scale measures health-related QoL, with scores ranging from 0 (death) to 1 (full health). A higher score indicates a better outcome. |
| HCP/Investigator burden for ONAPGO providers | Approximately 52-60 weeks | Change from baseline to each time point in scores over time on the modified 8-item HCP Burden Scale to assess the HCP perceived burden of managing patients on ONAPGO treatment |
Countries
United States
Contacts
Primary ContactMindy Grall, PhD ANP-BC
Backup ContactSupernus Supernus
Outcome results
None listed