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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.