An observational study in Parkinson Disease, sponsored by Supernus Pharmaceuticals, Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by Supernus Pharmaceuticals, Inc. · Observational
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
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 120 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are eligible for participation in this study after they have received a prescription for Onapgo
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).
Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
Titration Duration and Time to Optimized Dose
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
Time frame: Approximately 52-60 weeks
Concomitant Parkinson's Disease (PD) Medication Adjustments
Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. "Percentage of participants"
Time frame: Approximately 52-60 week
The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event
Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant
Time frame: Approximately 52-60 weeks
Perception of Patient Global Health Improvement
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)
Time frame: Approximately 52-60 weeks
Caregiver Burden
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.
Time frame: Approximately 52-60 weeks
HCP/Investigator burden for ONAPGO providers
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
Time frame: Approximately 52-60 weeks
Evaluation of ONAPGO usage during the maintenance period
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
Time frame: Approximately 52-60 weeks
Safety by monitoring adverse events (AEs)
Safety is measured by AE evaluation according to the standard of care and the percentage of participants who discontinue ONAPGO™ treatment due to AEs
Time frame: Approximately 52-60 weeks
Plan to share: No
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Supernus Pharmaceuticals, Inc.