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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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)
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NCT07145190