Real-World Study of SL-APO Use and Dose Adjustment in Parkinsons Disease OFF Episodes

What this Trial Is About

Researchers are conducting a prospective, observational study to collect real-world evidence on the use and dose adjustment of SL-APO sublingual apomorphine for treating OFF episodes in Parkinsons disease. The study aims to understand how SL-APO is used in practice, focusing on dose titration, individual dose determination, and how these factors influence patient satisfaction, treatment continuation, and the balance between effectiveness and safety. Participants start with a 10 mg dose of SL-APO during an OFF episode and undergo dose titration at home if the initial response is insufficient. Dose adjustments occur in 5 mg increments up to a maximum of 30 mg per dose, with no more than five doses daily and a minimum 2-hour interval between doses. The study includes a baseline visit, titration follow-up visits which may be calls or on-site, and maintenance dose tracking using patient diaries. Follow-up visits occur at 3 and 6 months, with the 6-month visit marking the studys end. During the study, participants keep a Patient Titration Diary from the second SL-APO intake until titration ends and then a Patient Maintenance Diary until study completion. Diaries document daily intake for the first week with at least 10 doses, then weekly entries. Researchers collect data on dose usage, dose adjustments, and patient outcomes without additional procedures beyond routine care. The primary outcome is identifying the most frequent dose used after adjustment, with safety and efficacy monitored through regular follow-ups over six months.

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