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RECRUITING
NCT07145190

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

Sponsor: Bial - Portela C S.A.

View on ClinicalTrials.gov

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

Interventions

DRUG

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