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
Summary For Families
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.
- 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.