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

NCT ID: NCT07219927

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-08-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational study

Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mindy Grall, PhD ANP-BC

Role: STUDY_CHAIR

Supernus Pharmaceuticals, Inc.

Locations

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

Aliso Viejo, California, United States

Site Status RECRUITING

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

Irvine, California, United States

Site Status RECRUITING

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

Site Status RECRUITING

Parkinson's Disease & Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status RECRUITING

Parkinson's Disease and Movement Disorders Center - Long Island

Commack, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mindy Grall, PhD ANP-BC

Role: CONTACT

18663980833

Supernus Supernus

Role: CONTACT

18663980833

Facility Contacts

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Mindy Bixby, D.O.

Role: primary

Sandeep Thakkar, D.O.

Role: primary

Salima Brillman, MD

Role: primary

Stuart Isaacson, MD

Role: primary

David Kreitzman, M.D.

Role: primary

Other Identifiers

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830P401

Identifier Type: -

Identifier Source: org_study_id

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