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

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

Overview

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.

Interventions

• Other Observational study
  Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Primary outcome measures

• Titration Duration and Time to Optimized Dose [Time frame: Approximately 52-60 weeks]
• Concomitant Parkinson's Disease (PD) Medication Adjustments [Time frame: Approximately 52-60 week]
• The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event [Time frame: Approximately 52-60 weeks]

Secondary outcome measures (5)

• Perception of Patient Global Health Improvement [Time frame: Approximately 52-60 weeks]
• Caregiver Burden [Time frame: Approximately 52-60 weeks]
• HCP/Investigator burden for ONAPGO providers [Time frame: Approximately 52-60 weeks]
• Evaluation of ONAPGO usage during the maintenance period [Time frame: Approximately 52-60 weeks]
• Safety by monitoring adverse events (AEs) [Time frame: Approximately 52-60 weeks]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 5 centers

• Parkinson's Disease and Movement Disorders Center - Orange County (South) — Aliso Viejo
• Parkinson's Disease and Movement Disorders Center - Orange County (North) — Irvine
• Parkinson's Research Centers of America - Palo Alto — Palo Alto
• Parkinson's Disease & Movement Disorders Center of Boca Raton — Boca Raton
• Parkinson's Disease and Movement Disorders Center - Long Island — Commack

Identifiers

NCT: NCT07219927 · 830P401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗