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

Supernus Pharmaceuticals

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT07219927

830P401

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).