Real-world experiences with ONAPGO continuous subcutaneous apomorphine infusion for Parkinson's disease in the U.S.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.