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
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
Enrollment
120
Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
Parkinson's Disease and Movement Disorders Center - Orange County (South)
Aliso Viejo, California, United States
RECRUITINGParkinson's Disease and Movement Disorders Center - Orange County (North)
Irvine, California, United States
RECRUITINGParkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States
Titration Duration and Time to Optimized Dose
The time from the date of ONAPGO™ initiation to the date of Dose Optimization Confirmation, as documented by the HCP/Investigator Unit of Measure: days
Time frame: Approximately 52-60 weeks
Concomitant Parkinson's Disease (PD) Medication Adjustments
Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. "Percentage of participants"
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
Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant
Time frame: Approximately 52-60 weeks
Perception of Patient Global Health Improvement
Change from baseline in the Patient Global Impression of Change (PGI-C) scale, with scores ranging from 1 ("very much improved") to 7 ("very much worse"); lower scores indicate better outcomes. Unit of Measure: PGI-C score (range 1-7)
Time frame: Approximately 52-60 weeks
Caregiver Burden
Change from baseline in caregiver quality of life (QoL) as determined by scores on the European Quality of Life 5 Dimensions (EQ-5D) scale. This scale measures health-related QoL, with scores ranging from 0 (death) to 1 (full health). A higher score indicates a better outcome.
Time frame: Approximately 52-60 weeks
HCP/Investigator burden for ONAPGO providers
Change from baseline to each time point in scores over time on the modified 8-item HCP Burden Scale to assess the HCP perceived burden of managing patients on ONAPGO treatment
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Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
RECRUITINGParkinson's Disease and Movement Disorders Center - Long Island
Commack, New York, United States
RECRUITINGTime frame: Approximately 52-60 weeks
Evaluation of ONAPGO usage during the maintenance period
Hourly modal infusion rate (mg/hour) during the maintenance period Daily modal dose (mg/day) during the maintenance period Daily modal duration (hour) during the maintenance period
Time frame: Approximately 52-60 weeks
Safety by monitoring adverse events (AEs)
Safety is measured by AE evaluation according to the standard of care and the percentage of participants who discontinue ONAPGO™ treatment due to AEs
Time frame: Approximately 52-60 weeks