Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) |
| Measure | Description | Time Frame |
|---|---|---|
| Titration Duration and Time to Optimized Dose | The time from the date of ONAPGOâ„¢ initiation to the date of Dose Optimization Confirmation, as documented by the HCP/Investigator Unit of Measure: days | 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" | 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 | Approximately 52-60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Approximately 52-60 weeks |
Not provided
Inclusion Criteria:
Participant has received a prescription for ONAPGOâ„¢ 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 ONAPGOâ„¢.
Prescribed ONAPGOâ„¢, but the HCP/Investigator determines the participant should not participate in this observational study.
Concomitant use of ONAPGOâ„¢ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron.
Known hypersensitivity to apomorphine or to excipients of ONAPGOâ„¢, including sulfite (e.g., sodium metabisulfite).
Not provided
Not provided
Not provided
Participants are eligible for participation in this study after they have received a prescription for Onapgo
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mindy Grall, PhD ANP-BC | Contact | 18663980833 | mgrall@supernus.com | |
| Supernus Supernus | Contact | 18663980833 |
| Name | Affiliation | Role |
|---|---|---|
| Mindy Grall, PhD ANP-BC | Supernus Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's Disease and Movement Disorders Center - Orange County (South) | Recruiting | Aliso Viejo | California | 92656 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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 | 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 | 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 ONAPGOâ„¢ treatment due to AEs | Approximately 52-60 weeks |
| Parkinson's Disease and Movement Disorders Center - Orange County (North) | Recruiting | Irvine | California | 92618 | United States |
|
| Parkinson's Research Centers of America - Palo Alto | Recruiting | Palo Alto | California | 94301 | United States |
|
| Parkinson's Disease & Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| Parkinson's Disease and Movement Disorders Center - Long Island | Recruiting | Commack | New York | 11725 | United States |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided