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EAN 2022 | Design of the EPSILON trial of opicapone as an add-on to levodopa in early PD

Joaquim Ferreira, MD, PhD, University of Lisbon, Lisbon, Portugal, describes the rationale and design of the Phase III, double-blind, randomized, placebo-controlled EPSILON trial (NCT04978597). The study is designed to evaluate the efficacy and safety of opicapone as an add-on to levodopa plus dopa decarboxylase inhibitor (DDCI) therapy in patients with early Parkinson’s disease (PD) without motor fluctuations. Currently, catechol-O-methyltransferase (COMT) inhibitors, such as opicapone, are used in patients who already exhibit signs of motor complications. The EPSILON study aims to investigate the efficacy of opicapone in enhancing the clinical benefit of levodopa in patients in earlier stages of PD without motor fluctuations. The primary efficacy endpoints are changes in Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III and Part IV total scores. This interview took place at the European Academy of Neurology (EAN) 2022 Congress in Vienna, Austria.

Disclosures

Received grants from GlaxoSmithKline, Grunenthal, Fundação MSD (Portugal), TEVA, MSD, Allergan, Novartis, Medtronic and Angelini. Received consultancy and speaker fees and participated in advisory boards for GlaxoSmithKline, Novartis, TEVA, Lundbeck, Solvay, BIAL, Merck-Serono, Merz, Ipsen, Biogen, Acadia, Allergan, Abbvie, Sunovion Pharmaceuticals, Zambon, Affiris, Roche, ONO and SK Chemicals.