SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
Recruiting · NCT07145190 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bial - Portela C S.A.
View the official record on ClinicalTrials.gov →Interventions studied
SL-APO
What this trial is about
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- The patient is ≥ 18 years of age.
- The patient has a clinical diagnosis of idiopathic Parkinson's disease.
- The patient will initiate SL-APO for the treatment of OFF episodes according to the SmPC.
- The patient is not currently on titration or maintenance dose for SL-APO.
- The patient has provided written informed consent to participate in this study.
Exclusion criteria
- The patient is participating in a clinical trial with an investigational drug.
- The patient has presented with dementia or evidence of cognitive decline as determined by the investigator.
- The patient has a history of psychotic disorder.
- The patient presents any other contraindication according to the SL-APO SmPC.
Where it is running
12 locations listed.
- 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