Category: Parkinson’s Disease: Clinical Trials
Objective: To develop a Phase IV study that can be used to inform best practice when considering continuous, subcutaneous apomorphine infusion (CSAI) as a treatment option for PD in the United States (US).
Background: Widely used for decades in Europe, Australia, and Asia, CSAI was approved in the US for the treatment of motor fluctuations in adults with advanced PD in February 2025. CSAI will be initiated and titrated in the outpatient setting with ongoing, in-home support by specialist Clinical Nurse Navigators.
Method: We conducted a series of interviews with US movement disorder experts to identify clinical and practical gaps in knowledge surrounding the use of CSAI that are necessary for clinicians to implement CSAI into their PD practice.
Results: Knowledge gaps included how to initiate and titrate CSAI in the outpatient setting, including handling of concomitant PD medication adjustments. The importance of good patient and care partner experience was highlighted, and it was recommended to capture their experiences to support ongoing program improvement and understand factors that contribute to treatment adherence and success. Based on these learnings, the phase IV, multicenter, observational study was designed to follow up to 120 patients with PD who have been prescribed CSAI for at least one year. The primary objectives are to evaluate initiation and titration practices for patients starting CSAI (outcomes include time from initiation to dose optimization, mean duration of intervals between each dose titration, and timing/order of concomitant PD medication adjustments during CSAI use). The secondary objectives are to evaluate the patient, care partner and HCP experiences when CSAI is added to the PD treatment regimen. Safety monitoring will be performed using routine post-marketing practices. In addition, self-report surveys have been designed to capture patient experiences using CSAI.
Conclusion: This phase IV study will be the first to document the real-world effectiveness and experiences of CSAI in the US.
To cite this abstract in AMA style:
M. Grall, A. Christiansen, N. Maskeri, S. Reyes, P. Qin, S. Isaacson. Continuous, Subcutaneous Apomorphine Infusion (CSAI) for PD: Development of a Phase IV routine practice study to capture the patient, care partner, and healthcare professional experience in the United States [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/continuous-subcutaneous-apomorphine-infusion-csai-for-pd-development-of-a-phase-iv-routine-practice-study-to-capture-the-patient-care-partner-and-healthcare-professional-experience-in-the-united/. Accessed October 5, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/continuous-subcutaneous-apomorphine-infusion-csai-for-pd-development-of-a-phase-iv-routine-practice-study-to-capture-the-patient-care-partner-and-healthcare-professional-experience-in-the-united/