Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:

NCT07219927 · tracked via the Priya Life Science USA tracker

Sponsor

Supernus Pharmaceuticals, Inc.

Phase

Observational

Started

2025-03-31

Last updated

2025-10-22

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Observational study

Observational study: Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

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

Trial sites (5)

Facility	City	Region	Status
Parkinson's Disease and Movement Disorders Center - Orange County (South)	Aliso Viejo	California	Recruiting
Parkinson's Disease and Movement Disorders Center - Orange County (North)	Irvine	California	Recruiting
Parkinson's Research Centers of America - Palo Alto	Palo Alto	California	Recruiting
Parkinson's Disease & Movement Disorders Center of Boca Raton	Boca Raton	Florida	Recruiting
Parkinson's Disease and Movement Disorders Center - Long Island	Commack	New York	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219927 on ClinicalTrials.gov ↗ ← All trials in the USA