Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Opicapone (OPC) is a third generation catechol O methyltransferase (COMT) inhibitor (COMTi)
developed by BIAL-Portela & Cª, S.A. It is approved as adjunctive therapy to preparations of
L-DOPA/DDCI in adult patients with Parkinson's disease and end-of-dose motor fluctuations who
cannot be stabilized on those combinations. Carbidopa and benserazide are both DDCIs used in
association with L DOPA. When OPC is co administered with L DOPA/DDCI, peripheral COMT is
inhibited and thus L DOPA plasma levels increase, increasing L DOPA bioavailability. The
purpose of this Phase III study is to explore the potential of OPC to enhance the clinical
benefit of L-DOPA in L DOPA treated patients in the early stages of Parkinson's Disease (PD)
(patients without end-of-dose motor fluctuations, 'non fluctuators').