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NCT07219927Recruiting

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

Supernus Pharmaceuticals, Inc.

Start Date

3/31/2025

Completion Date

8/1/2027

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

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

OTHER

Observational study

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Conditions

Parkinson Disease

Locations

Parkinson's Disease and Movement Disorders Center - Orange County (South)

Aliso Viejo, California 92656

United States

Parkinson's Disease and Movement Disorders Center - Orange County (North)

Irvine, California 92618

United States

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California 94301

United States

Parkinson's Disease & Movement Disorders Center of Boca Raton

Boca Raton, Florida 33486

United States

Parkinson's Disease and Movement Disorders Center - Long Island

Commack, New York 11725

United States