SL-APO for Parkinson's (NCT07145190)
Find right on demand dose
- 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
- Find right on demand dose
- 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 collect real-world information on how people use SL-APO as an on-demand treatment and how finding the right individual dose affects patient satisfaction, whether people stay on the treatment, and the balance between benefit and side effects. The study follows patients who are already prescribed SL-APO in routine care: the first 10 mg dose is checked in the clinic while symptoms are in the OFF state, dose finding continues at home if needed, patients keep short titration and maintenance diaries, and follow-up calls or visits happen at about 3 and 6 months; no extra tests are required and receiving the drug is not tied to joining the study. Adults 18 and older with diagnosed Parkinson's who will start SL-APO for OFF episodes according to the product label, who are not already on SL-APO titration or maintenance, and who can give written consent are eligible, while people in other drug trials, with dementia or psychotic disorder, or with contraindications per the product label are excluded.
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 collect real-world information on how people use SL-APO as an on-demand treatment and how finding the right individual dose affects patient satisfaction, whether people stay on the treatment, and the balance between benefit and side effects. The study follows patients who are already prescribed SL-APO in routine care: the first 10 mg dose is checked in the clinic while symptoms are in the OFF state, dose finding continues at home if needed, patients keep short titration and maintenance diaries, and follow-up calls or visits happen at about 3 and 6 months; no extra tests are required and receiving the drug is not tied to joining the study. Adults 18 and older with diagnosed Parkinson's who will start SL-APO for OFF episodes according to the product label, who are not already on SL-APO titration or maintenance, and who can give written consent are eligible, while people in other drug trials, with dementia or psychotic disorder, or with contraindications per the product label are excluded.
- 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?
- 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 5 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.
- How many visits does this trial involve?
- Site visits are scheduled at baseline and at 3 and 6 months, with the 6-month visit marking the end of the study (6 months total).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.