Objective: A patient’s early experience with a new medication is critical to medication adherence and overall treatment outcomes. The SL-START study aims to characterize how sublingual apomorphine (SL-APO) is initiated, titrated, and used in routine clinical practice.

Background: Parkinson’s disease patients (PDP) experiencing motor fluctuations often suffer problems such as morning akinesia, delays in time-to-ON, and unpredictable OFF episodes with their levodopa regimen. APO is a potent, rapidly acting dopamine agonist with broad, ‘dopamine-like’ affinity at both D1-family and D2-family receptors. It requires individualized titration to optimal effectiveness while balancing tolerability. SL-APO film offers PDP an easy-to-administer, non-invasive, on-demand treatment option for a quick and reliable transition from OFF to ON.

Method: SL-START is a prospective, observational, 6-month study of SL-APO to be conducted at 12 sites across Germany. PDP (≥18y) experiencing intermittent OFF episodes not sufficiently controlled by oral antiparkinsonian medication are eligible if they have been prescribed SL-APO for the management of OFF episodes. Participants will be assessed at baseline, during titration, and after 3 and 6 months.

Results: The primary objective is to identify the different titration schemes, most frequent optimal dose after adjustment, median time to optimal dose and type of OFF episode used for dose-adjustment. Details of the SL-APO regimen, use of domperidone, and other PD medications will be documented. Clinician (CGI-C) and Patient (PGI-C) Global Impressions of Change and satisfaction with SL-APO will also be captured. Safety and tolerability will be assessed via adverse event reporting and the number of treatment discontinuations.

Conclusion: SL-START will inform on the factors of SL-APO titration that are important for patient retention and guide best practice for SL-APO titration strategies in real-world practice.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/sl-start-a-multicentre-observational-study-of-sublingual-apomorphine-titration-and-usage-schemes-in-routine-practice/