Observational study for Parkinson's (NCT07219927)
Reduce off time and fluctuations
- Trial ID
- NCT07219927
- 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
- Goal
- Reduce off time and fluctuations
- Status
- RECRUITING
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Study Type
- OBSERVATIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease
- Interventions
- Observational study
Summary For Families
The goal is to collect real-world patient experiences with continuous subcutaneous apomorphine infusion (ONAPGO) in the United States, to learn how it affects motor fluctuations, off time, and overall tolerability in routine care. ONAPGO delivers apomorphine, a fast-acting dopamine agonist, as a steady under-the-skin infusion to stimulate dopamine receptors and smooth out levodopa wearing-off and sudden off periods, and it is often used alongside levodopa, but it can interact dangerously with 5-HT3 antagonist antiemetics and can cause reactions in people with sulfite sensitivity. Adults 18 and older who have already been prescribed ONAPGO and who opt into support from a Clinical Nurse Navigator are eligible, while those the clinician deems inappropriate, those taking 5-HT3 antagonists, or those with known apomorphine or sulfite allergy are excluded.
Locations
- Parkinson's Disease and Movement Disorders Center - Orange County (South), Aliso Viejo, California, United States
- Parkinson's Disease and Movement Disorders Center - Orange County (North), Irvine, California, United States
- Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States
- Parkinson's Disease & Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States
- Parkinson's Disease and Movement Disorders Center - Long Island, Commack, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Observational study. The goal is to collect real-world patient experiences with continuous subcutaneous apomorphine infusion (ONAPGO) in the United States, to learn how it affects motor fluctuations, off time, and overall tolerability in routine care. ONAPGO delivers apomorphine, a fast-acting dopamine agonist, as a steady under-the-skin infusion to stimulate dopamine receptors and smooth out levodopa wearing-off and sudden off periods, and it is often used alongside levodopa, but it can interact dangerously with 5-HT3 antagonist antiemetics and can cause reactions in people with sulfite sensitivity. Adults 18 and older who have already been prescribed ONAPGO and who opt into support from a Clinical Nurse Navigator are eligible, while those the clinician deems inappropriate, those taking 5-HT3 antagonists, or those with known apomorphine or sulfite allergy are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.