Recruiting

Apomorphine

Sponsor:

Supernus Pharmaceuticals, Inc.

Code:

NCT07219927

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational study

Study Details

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

Study ID

NCT07219927

Start date

Mar 31, 2025

Status verified date

Oct, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Observational study

Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)

Primary outcome measure

  • Titration Duration and Time to Optimized Dose [ Time Frame: Approximately 52-60 weeks ]
  • Concomitant Parkinson's Disease (PD) Medication Adjustments [ Time Frame: 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 [ Time Frame: Approximately 52-60 weeks ]

Central Contacts and Locations

Central contacts

Mindy Grall, PhD ANP-BC

18663980833mgrall@supernus.com

Supernus Supernus

18663980833

Locations

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

Recruiting

Aliso Viejo, California, United States, 92656

Principal Investigator:

Mindy Bixby, D.O.

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

Recruiting

Irvine, California, United States, 92618

Principal Investigator:

Sandeep Thakkar, D.O.

Parkinson's Research Centers of America - Palo Alto

Recruiting

Palo Alto, California, United States, 94301

Principal Investigator:

Salima Brillman, MD

Parkinson's Disease & Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

Principal Investigator:

Stuart Isaacson, MD

Parkinson's Disease and Movement Disorders Center - Long Island

Recruiting

Commack, New York, United States, 11725

Principal Investigator:

David Kreitzman, M.D.

More Information

Sponsor

Supernus Pharmaceuticals, Inc.

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • ONAPGO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc. on 2025-10-22.