Objective: To assess the safety and tolerability of levodopa-carbidopa intestinal gel (LCIG, designated in the United States as carbidopa-levodopa enteral suspension) in advanced Parkinson’s disease (PD) patients in the final Phase 3, open-label, continued access to treatment study from the US registration program.

Background: LCIG is continuously delivered via percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced PD patients with motor fluctuations that have not been adequately controlled by available oral anti-Parkinsonian medications.

Methods: The study enrolled advanced PD patients (N=262) who had completed either a 12-week double-blind study and its 52-week open-label extension (ref 1) or a separate 54-week open-label study (ref 2). Patients could remain in the study until LCIG was commercially available. Treatment-emergent adverse events through October 2015 were summarized. The efficacy data from the US subset of patients are reported in a separate abstract.

Results: Mean total exposure to LCIG was 4.1 years, and most of the exposure to LCIG and PEG-J occurred during this study (Table 1). At the data cutoff, 110 patients (42%) had completed the study and begun treatment with commercial LCIG, 89 (34%) had prematurely discontinued for any reason, and 63 (24%) were still ongoing. Most patients (246, 94%) had an AE, and 140 (53%) had a serious AE (the most frequently reported in Table 2). Of the 89 patients who discontinued treatment, 62 (62/262, 24%) did so because of an AE. There were 38 deaths (15%), of which, 2 (intestinal dilatation and cardiac arrest) were considered possibly related to treatment by the investigator, and the rest were unrelated.