Objective: To describe and to evaluate a Balearic ongoing Parkinson’s disease (PD) Project to evaluate the efficacy and tolerance of the interaction between safinamide and opicapone on motor and non-motor symptoms in fluctuating PD patients on levodopa-therapy.

Background: Current treatment of PD is mainly based on dopaminergic drugs. Levodopa (LD) continues to be the most effective drug for symptomatic treatment of PD. Recently two new drugs have been marketed: safinamide (1) and opicapone (2). However, interaction between both has not been investigated yet. We hypothesized that, due to the different mechanism of action of both drugs, they could present synergy in effectiveness, without major side effects.

Methods: Observational, descriptive, non-interventional, cross-sectional, 3 months follow-up, autonomic (Balearic Island), multicenter, evaluation study. Objective: to study a population of around 70 patients with fluctuating PD on LD-therapy. Patients will be evaluated at baseline before the beginning of the second pharmacological treatment (patient who were with safinamide to which opicapone is added or vice versa) and 12 weeks after. All patients will perform a comprehensive motor and non-motor assessment that consists in tests to evaluate the following domains: gait, digital abilities, pain, quality of life, cognitive functions, neuropsychiatric disorders, and sleep disturbances (Hoenh&Yahr, UPDRS, FOGQ, Hauser patient diaries, MoCA, NMSS, PDSS, VAS-Pain, VAS-Fatigue, KPPS, BDI- II, QUIP-RS, ADLS, PDQ-39SI, PQ-10).

Results: There are no definite results at present. Study periods: Recruitment period from February 1, 2018 to June 31, 2018. Follow-up period, 3 months. Many of the public and private hospitals of Balearic Island participate as referral centers. The evaluation will be carried out in a public hospital (Son Espases) and in a a private center (Quirón Palmaplanas). We hope to present results of 40 patients on the dates of the congress.

Conclusions: We expect to find a possible synergy between safinamide and opicapone, without significant side effects.

References: 1. Borgohain R, Szasz J, Stanzione P, Meshram C, Bhatt MH, Chirilineau D, Stocchi F, Lucini V, Giuliani R, Forrest E, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease. Mov Disord (2014) 29:1273-1280. doi:10.1002/mds.25961. 2. Ferreira JJ, Lees A, Rocha J-F, Poewe W, Rascol O, Soares-da-Silva P. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol (2016) 15:154-165. doi:10.1016/S1474-4422(15)00336-1.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/evaluation-of-the-interaction-between-safinamide-and-opicapone-in-parkinsons-disease-patients-with-fluctuations/