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NCT07219927 | RECRUITING | Parkinson Disease

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

Supernus Pharmaceuticals, Inc.

Brief 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

Condition or disease

Parkinson Disease

Intervention/treatment

Observational study

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 120 participants
Official Title : 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
Actual Study Start Date : 2025-03-31
Estimated Primary Completion Date : 2027-08-01
Estimated Study Completion Date : 2027-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:

Location Details

NCT07219927

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

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

Old Alder, California, United States, 92656

RECRUITING

United States, California

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

Irvine, California, United States, 92618

RECRUITING

United States, California

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States, 94301

RECRUITING

United States, Florida

Parkinson's Disease & Movement Disorders Center of Boca Raton

Boca Raton, florida, United States, 33486

RECRUITING

United States, New York

Parkinson's Disease and Movement Disorders Center - Long Island

Commack, New York, United States, 11725