observational study
OtherContinuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
NCT Number: NCT07219927
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Parkinson's Disease and Movement Disorders Center - Orange County (South), Aliso Viejo, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
Time frame: Approximately 52-60 weeks
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 week
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 weeks
Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant
Time frame: Approximately 52-60 weeks
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
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
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
Time frame: Approximately 52-60 weeks
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 is measured by AE evaluation according to the standard of care and the percentage of participants who discontinue ONAPGO™ treatment due to AEs
Contact information is provided by the study sponsor or research team.
Supernus Pharmaceuticals, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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