Status:
RECRUITING
Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
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
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07219927
Start Date
March 31 2025
End Date
August 1 2027
Last Update
October 22 2025
Active Locations (5)
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1
Parkinson's Disease and Movement Disorders Center - Orange County (South)
Aliso Viejo, California, United States, 92656
2
Parkinson's Disease and Movement Disorders Center - Orange County (North)
Irvine, California, United States, 92618
3
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States, 94301
4
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486