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SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
Sponsor: Bial - Portela C S.A.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2025-08-27
Completion Date
2028-02
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
SL-APO
Patients should start with a dose of 10 mg SL-APO. Dose initiation should occur when the patient is having an OFF episode. If the patient tolerates the 10 mg dose, and responds adequately (meaning satisfactory motor response within 30 minutes), the maintenance dose should be 10 mg. If the dose is tolerated but the response is insufficient, continue to titrate in 5 mg increments when the patient is having an OFF episode and assess response until an effective and tolerable dose is achieved, up to a maximum of 30 mg per dose and up to five times a day. If an "ON" response is achieved and if clinically warranted, consider the need to further up-titrate as tolerated to achieve a better "ON" response. The minimal interval between doses is 2 hours, with no more than one dose of SL-APO per OFF episode.
Locations (12)
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