Levodopa‐Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial

Abstract

ABSTRACTBackgroundThere are limited data regarding the effectiveness of levodopa‐carbidopa intestinal gel (LCIG) for dyskinesia.ObjectiveCompare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson's disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS).MethodsThis phase 3b, open‐label, multicenter, 12‐week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD‐related motor and non‐motor symptoms, and quality of life (QoL) were also assessed.ResultsDyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; −17.37 ± 2.79) compared with the OMT group (n = 26; −2.33 ± 2.56) after 12 weeks (−15.05 ± 3.20; 95% CI, −21.47 to −8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in “On” time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson's Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment‐emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG‐treated patients.ConclusionsLCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and non‐motor symptoms and QoL. © 2021 AbbVie Inc. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson Movement Disorder Society