Parkinson DiseaseNCT07219927
Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:
An observational study of Parkinson Disease, run by Supernus Pharmaceuticals, Inc. at 5 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Observational study
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Mar 2025to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are eligible for participation in this study after they have received a prescription for Onapgo
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Supernus Supernus contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Parkinson's Disease and Movement Disorders Center - Orange County (South)
Aliso Viejo, California, 92656
Mindy Bixby, D.O.
Mindy Bixby, D.O.
- Recruiting
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Stuart Isaacson, MD
Stuart Isaacson, MD
- Recruiting
Parkinson's Disease and Movement Disorders Center - Long Island
Commack, New York, 11725
David Kreitzman, M.D.
David Kreitzman, M.D.
- Recruiting
Parkinson's Disease and Movement Disorders Center - Orange County (North)
Irvine, California, 92618
Sandeep Thakkar, D.O.
Sandeep Thakkar, D.O.
- Recruiting
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301
Salima Brillman, MD
Salima Brillman, MD
About this study
Official title: Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease
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
Read the detailed description
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
- Parkinson Disease
- Being tested
- Observational study
- Keywords
- ONAPGO
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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"
Measured: 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
Measured: Approximately 52-60 weeks
Secondary outcomes (5)
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)
Measured: Approximately 52-60 weeks
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.
Measured: 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
Measured: 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
Measured: 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 ONAPGO™ treatment due to AEs
Measured: Approximately 52-60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start31 Mar 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mindy Grall, PhD ANP-BC, Study chair, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219927
- Sponsor's protocol ID
- 830P401
- Status last verified
- Oct 2025
- First submitted
- 9 Jun 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07219927
- Acronym / sponsor ID
- 830P401
- Conditions
- Parkinson Disease
- Keywords
- ONAPGO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are eligible for participation in this study after they have received a prescription for Onapgo
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyContinuous Subcutaneous Apomorphine Infusion (ONAPGOTM) | Other | – |
Primary outcome
Titration Duration and Time to Optimized Dose
Time frame: Approximately 52-60 weeks
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
Concomitant Parkinson's Disease (PD) Medication Adjustments
Time frame: Approximately 52-60 week
Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP/Investigator. "Percentage of participants"
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
Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant
5 secondary outcomes
Perception of Patient Global Health Improvement
Time frame: Approximately 52-60 weeks
Caregiver Burden
Time frame: Approximately 52-60 weeks
HCP/Investigator burden for ONAPGO providers
Time frame: Approximately 52-60 weeks
Evaluation of ONAPGO usage during the maintenance period
Time frame: Approximately 52-60 weeks
Safety by monitoring adverse events (AEs)
Time frame: Approximately 52-60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Supernus Supernus contact
Mindy Grall, PhD ANP-BC study chair
Supernus Pharmaceuticals, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Supernus Pharmaceuticals, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mindy Grall, PhD ANP-BC (18663980833, mgrall@supernus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titration Duration and Time to Optimized Dose (time frame: Approximately 52-60 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.