SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START
Bial - Portela C S.A.
90 participants
Aug 27, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07145190