Sublingual apomorphine titration for Parkinson's OFF episodes

SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START

This project will collect real-world information to see how adults with Parkinson's start and adjust sublingual apomorphine (Kynmobi) for OFF episodes and how those dosing choices affect satisfaction, continued use, effectiveness, and side effects.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bial - Portela C S.A. (Industry-sponsored)
• Locations: 12 sites (Berlin and 11 other locations)
• Trial ID: NCT07145190 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, non-interventional real-world evidence effort enrolling adults with idiopathic Parkinson's who are starting sublingual apomorphine per the product label. At baseline the tolerance and efficacy of a 10 mg dose will be observed in the OFF state, and patients with insufficient response will continue home titration following routine clinical practice. Follow-up contacts—by phone or on-site—will record the dose at which patients reach their preferred balance of effect and tolerability, along with measures of persistence, satisfaction, and safety. No extra procedures beyond usual care are required and treatment decisions remain independent of study participation.

Who should consider this trial

Good fit: Adults (≥18) with idiopathic Parkinson's disease who are about to initiate sublingual apomorphine for OFF episodes and are not currently on a titration or maintenance dose.

Not a fit: Patients with dementia or cognitive decline, a history of psychotic disorder, any contraindication per the SL-APO label, or participation in another investigational drug trial are unlikely to benefit from this observational dataset.

Why it matters

Potential benefit: If successful, the data could help optimize real-world titration approaches so patients achieve effective OFF relief with fewer side effects and improved treatment satisfaction and persistence.

How similar studies have performed: Clinical trials and some real-world reports have shown sublingual apomorphine can relieve OFF episodes, but targeted prospective real-world studies focused on routine titration practices remain limited.

Eligibility criteria

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 this trial is running

Berlin and 11 other locations

• Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation — Berlin, Germany (Recruiting)
• Alexianer St. Joseph Berlin-Weißensee GmbH — Berlin, Germany (Not_yet_recruiting)
• Praxis für Neurologie — Berlin, Germany (Recruiting)
• Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie — Bochum, Germany (Not_yet_recruiting)
• UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum — Freiburg im Breisgau, Germany (Not_yet_recruiting)
• Praxis für Neurologie und Psychiatrie — Fulda, Germany (Recruiting)
• Klinik am Tharandter Wald — Hetzdorf, Germany (Recruiting)
• Klinik für Neurologie und Neurologische Frührehabilitation — Osnabrück, Germany (Not_yet_recruiting)
• Die Nerven Docs — Siegen, Germany (Recruiting)
• Neurologische Klinik Sorpesee — Sundern, Germany (Recruiting)
• Praxis für Neurologie und Geriatrie — Ulm, Germany (Recruiting)
• Neurologie am Funkerberg — Wusterhausen, Germany (Recruiting)

Study contacts

• Principal investigator: Jan Kassubek, Prof Dr med — Praxis für Neurologie und Geriatrie (Ulm)
• Study coordinator: Ruben Arnelas

Conditions Parkinson Disease; Kynmobi; SL-APO