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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSupernus Pharmaceuticals, Inc.

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Participants are eligible for participation in this study after they have received a prescription for Onapgo

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational study

    Other intervention

    Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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

Time frame
Approximately 52-60 weeks
4

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

Other outcomes

Sponsors and contacts

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