Real-world experiences with ONAPGO continuous subcutaneous apomorphine infusion for Parkinson's disease in the U.S.
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
This project will collect real-world experiences to see how continuous subcutaneous ONAPGO infusion works for people with Parkinson's disease who have been prescribed it in the United States.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Supernus Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 5 sites (Aliso Viejo, California and 4 other locations) |
| Trial ID | NCT07219927 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, phase 4 observational program that follows patients from prescription through initiation, titration, and maintenance of ONAPGO with standard-of-care nursing support. Participants have an Enrollment Day, a Baseline Period that includes in-home education by a Clinical Nurse Navigator, a Dose Initiation/Titration/Optimization period, routine maintenance visits, and an End-of-Study or discontinuation visit. Data are collected according to usual clinical practice without investigational interventions beyond the prescribed ONAPGO product and support services. The goal is to describe real-world use patterns, tolerability, dosing, and patient experiences across participating U.S. centers.
Who should consider this trial
Good fit: Ideal candidates are people with Parkinson's disease who have received a prescription for ONAPGO, have opted into Clinical Nurse Navigator support, and can provide informed consent.
Not a fit: Patients who were not prescribed ONAPGO, who cannot receive ONAPGO due to hypersensitivity, or who require contraindicated medications (such as 5-HT3 antagonists) are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help patients and clinicians understand real-world tolerability, dosing patterns, and support needs for ONAPGO, potentially improving symptom management and care coordination.
How similar studies have performed: Continuous subcutaneous apomorphine infusion as a treatment for motor fluctuations has prior clinical evidence of benefit, but prospective real-world observational data specifically for the ONAPGO formulation are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Aliso Viejo, California and 4 other locations
- Parkinson's Disease and Movement Disorders Center - Orange County (South) — Aliso Viejo, California, United States (Recruiting)
- Parkinson's Disease and Movement Disorders Center - Orange County (North) — Irvine, California, United States (Recruiting)
- Parkinson's Research Centers of America - Palo Alto — Palo Alto, California, United States (Recruiting)
- Parkinson's Disease & Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (Recruiting)
- Parkinson's Disease and Movement Disorders Center - Long Island — Commack, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mindy Grall, PhD ANP-BC
- Email: mgrall@supernus.com
- Phone: 18663980833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.