Map rescue medication dosing patterns
- Trial ID
- NCT07145190
- Official Title
- SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START
- Goal
- Map rescue medication dosing patterns
- Status
- RECRUITING
- Sponsor
- Bial - Portela C S.A.
- Study Type
- OBSERVATIONAL
- Enrollment
- 90 participants
- Conditions
- Parkinson Disease
- Interventions
- SL-APO
Plain-Language Summary
The goal is to map how people actually start and use sublingual apomorphine for OFF episodes, so doctors and patients can learn practical titration and dosing patterns. Participants who are beginning SL-APO per the product label will be followed without changing their care; apomorphine is a fast-acting dopamine agonist that directly stimulates dopamine receptors to quickly reverse OFF symptoms, working as a rescue on top of regular levodopa rather than replacing it. The study seeks adults 18 and older with idiopathic Parkinson's who are about to start SL-APO and are not already on a titration or maintenance dose, and it excludes people with dementia, psychotic disorders, other contraindications on the product label, or who are in another investigational drug trial.
Locations
- Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation, Berlin, Germany
- Alexianer St. Joseph Berlin-Weißensee GmbH, Berlin, Germany
- Praxis für Neurologie, Berlin, Germany
- Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie, Bochum, Germany
- UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum, Freiburg im Breisgau, Germany
- Praxis für Neurologie und Psychiatrie, Fulda, Germany
- Klinik am Tharandter Wald, Hetzdorf, Germany
- Klinik für Neurologie und Neurologische Frührehabilitation, Osnabrück, Germany
- Die Nerven Docs, Siegen, Germany
- Neurologische Klinik Sorpesee, Sundern, Germany
- Praxis für Neurologie und Geriatrie, Ulm, Germany
- Neurologie am Funkerberg, Wusterhausen, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SL-APO. The goal is to map how people actually start and use sublingual apomorphine for OFF episodes, so doctors and patients can learn practical titration and dosing patterns. Participants who are beginning SL-APO per the product label will be followed without changing their care; apomorphine is a fast-acting dopamine agonist that directly stimulates dopamine receptors to quickly reverse OFF symptoms, working as a rescue on top of regular levodopa rather than replacing it. The study seeks adults 18 and older with idiopathic Parkinson's who are about to start SL-APO and are not already on a titration or maintenance dose, and it excludes people with dementia, psychotic disorders, other contraindications on the product label, or who are in another investigational drug trial.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 12 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 5 months.