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Recruiting NCT07145190

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

Conditions: Parkinson Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 90
Sponsor: Bial - Portela C S.A.

Location: Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation Berlin

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07145190). StuddyBuddy aggregates publicly available trial information.