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

NCT07219927 | Recruiting

• 1 other identifier: 830P401
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Parkinson Disease

Keywords

ONAPGO

Outcome Measures

Primary Outcomes (3)

• 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

  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

Secondary Outcomes (5)

• Perception of Patient Global Health Improvement

  Approximately 52-60 weeks

• Caregiver Burden

  Approximately 52-60 weeks

• HCP/Investigator burden for ONAPGO providers

  Approximately 52-60 weeks

• Evaluation of ONAPGO usage during the maintenance period

  Approximately 52-60 weeks

• Safety by monitoring adverse events (AEs)

  Approximately 52-60 weeks

Interventions

Observational study OTHER

Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (5)

Parkinson's Disease and Movement Disorders Center - Orange County (South)

Aliso Viejo, California, 92656, United States

RECRUITING

Parkinson's Disease and Movement Disorders Center - Orange County (North)

Irvine, California, 92618, United States

RECRUITING

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

RECRUITING

Parkinson's Disease & Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

RECRUITING

Parkinson's Disease and Movement Disorders Center - Long Island

Commack, New York, 11725, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mindy Grall, PhD ANP-BC

  Supernus Pharmaceuticals, Inc.

  STUDY CHAIR

Central Study Contacts

Mindy Grall, PhD ANP-BC

CONTACT

18663980833; mgrall@supernus.com

Supernus Supernus

CONTACT

18663980833

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: October 22, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)