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
Plain-Language Summary
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.