SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment

Recruiting now

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT07145190

Run by

Bial - Portela C S.A.

People needed

90

Starts

2025-08-27

Expected to finish

2028-02-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Neurologie am Funkerberg — Wusterhausen, Germany (enrolling)
• Die Nerven Docs — Siegen, Germany (enrolling)
• Neurologische Klinik Sorpesee — Sundern, Germany (enrolling)
• Praxis für Neurologie und Geriatrie — Ulm, Germany (enrolling)
• Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation — Berlin, Germany (enrolling)
• Praxis für Neurologie — Berlin, Germany (enrolling)
• Praxis für Neurologie und Psychiatrie — Fulda, Germany (enrolling)
• Klinik am Tharandter Wald — Hetzdorf, Germany (enrolling)
• Alexianer St. Joseph Berlin-Weißensee GmbH — Berlin, Germany
• Klinik für Neurologie und Neurologische Frührehabilitation — Osnabrück, 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

Full record on ClinicalTrials.gov

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