Outpatient levodopa-carbidopa intestinal gel titration in patients with advanced Parkinson's disease

Abstract

s / Parkinsonism and Related Disorders 22 (2016) e16ee20 e17 OP 2.50.17. OUTPATIENT LEVODOPA-CARBIDOPA INTESTINAL GEL TITRATION IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE Ramon Rodriguez , Michael Lobatz , Jordan Dubow, Susan Eaton , Coleen Hall , Krai Chatamra , Janet Benesh . University of Florida College of Medicine, Gainesville, United States; Neurology Center of Southern California, Oceanside, United States; AbbVie Inc., North Chicago, United States Objectives: To evaluate outpatient titration of levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) monotherapy via percutaneous gastrojejunostomy (PEG-J) in an ongoing, 60week, open-label, multicenter, safety and efficacy study. Methods: LCIG titration was initiated as monotherapy in an outpatient setting within 5 days of PEG-J procedure and continued up to 4 weeks, reaching completion when dose was unadjusted for 7 days. Investigators could admit subjects for observation for up to 48 hours following PEG-J placement. Safety was assessed throughout the study and summarized for the first 4 weeks. Results: Mean (SD) age was 64 (10) years. Post-PEG-J placement, mean (SD) hours until discharge was 19.2 (15.3) with a mean 29.3 (39.9) hours until titration initiation (n1⁄438). On average (SD, range), LCIG titration was completed in 6.4 (5.4, 1e33) days (n1⁄437). Week 1, the mean time in an outpatient facility ranged from 3.0 to 7.3 hours/day.[Table1] The majority of patients had an adverse event (AE) within the first week of PEG-J placement, with fewer in the following 3 weeks.[Table 2] Mean (SD) initial planned levodopa dose was 1233.8 (475.7) mg/day (n1⁄438); the mean (SD) change to final dose was 446.1 (615.6) mg/day. Table 1 Average number of hours of titrating LCIG in an outpatient clinic during the first seven d Daily hours of titration following initiation of LCIG infusion n (%) Day 1 38 (100%) Day 2 36 (95%) Day 3 20 (53%) Day 4 12 (32%) Day 5 10 (26%) Day 6 7 (18%) Day 7 3 (8%) a Data were collected by certified nurse educators, N1⁄438. b n of subjects who had an office visit or phone call consultation on that day. Table 2 Incidence of adverse events in outpatients during the first four weeks Post-PEG-J Placement n (%) patients Post-PEG-J Placement Week 1 Week 2 Week 3 Week 4 Weeks 1e4 Any adverse event (AE) 24 (62%) 7(18%) 2 (5.1%) 6 (16%) 28(72%) Any serious AE 3 (7.7%) 0 0 0 3 (7.7%) Any AE leading to discontinuation 1 (2.6%) 0 0 0 1 (2.6%) Deaths 0 0 0 0 0 AEs Occurring in 2 patients: Procedural pain 13 (33%) 0 0 0 13 (33%) Anxiety 5 (13%) 0 0 0 5 (13%) Catheter site pain 3 (7.7%) 0 0 0 3 (7.7%) Stoma site infection 3 (7.7%) 0 0 0 3 (7.7%) Urinary tract infection 1 (2.6%) 1 (2.6%) 1 (2.6%) 0 3 (7.7%) Abdominal distension 2 (5.1%) 0 0 0 2 (5.1%) Catheter site infection 0 2 (5.1%) 0 1 (2.6%) 2 (5.1%) Constipation 2 (5.1%) 0 0 0 2 (5.1%) Dry mouth 2 (5.1%) 0 0 0 2 (5.1%) Flatulence 2 (5.1%) 0 0 0 2 (5.1%) Fall 0 1 (2.6%) 0 2 (5.1%) 2 (5.1%) Hyperhidrosis 1 (2.6%) 0 1 (2.6%) 0 2 (5.1%) a N1⁄439. b MedDRA preferred terms. Conclusions: Data support the idea that LCIG can be safely and effectively titrated in outpatient settings. OP 2.50.18. EFFECTS OF LEVODOPA-CARBIDOPA INTESTINAL GEL ON NON-MOTOR SYMPTOMS AND SAFETY OF OUTPATIENT TITRATION: A NEW PHASE 3 STUDY IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE David Standaert , John Slevin , Coleen Hall , Jordan Dubow, Susan Eaton , Krai Chatamra , Janet Benesh . University of Alabama at Birmingham, Birmingham, United States; University of Kentucky Medical Center, Lexington, United States; AbbVie Inc., North Chicago, United States Objectives: Assess the efficacy of levodopa-carbidopa intestinal gel (LCIG/ carbidopa-levodopa enteral suspension [CLES]) on non-motor symptoms (NMS) and the safety of outpatient LCIG titration in patients with advanced Parkinson’s disease (PD). Methods: In this ongoing, 60-week, open-label Phase 3 study, patients underwent outpatient LCIG titration within 5 days of PEG-J placement. Optimized LCIG monotherapy was administered daily over 16 waking hours. Evaluations included mean change from baseline to week 12 on the Non-Motor Symptom Scale (NMSS) total score (primary endpoint), NMSS domain scores, and PD diary measures. Abstract is interim data; however the week 12 primary endpoint is final. Results: As of March 2015, 39 patients were enrolled: mean(SD) age was 64.3(10.2) years and the first planned LCIG dose was 1233.8(475.7) mg/day (n 1⁄4 38). The NMSS total score and 6 of the domain scores were reduced at week 12 compared to baseline. [Table1] Normalized “off” time and “on” time without TSD showed improvement.[Figure 1] Interim safety is sum-