About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Participants are eligible for participation in this study after they have received a prescription for Onapgo
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational study
Other interventionContinuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
Treatment groups
Trial outcomes
Primary outcomes
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
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"
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
Secondary outcomes
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)
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.
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
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
Sponsors and contacts
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