NCT04978597

Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)

A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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').

Detailed description

This is a Phase III study to evaluate the efficacy and safety of OPC in subjects with early idiopathic PD receiving treatment with L DOPA plus a DDCI, and who are without signs of any motor complication (consisting of fluctuations in the motor response and/or involuntary movements or dyskinesias). After a screening period of up to 4 weeks, eligible subjects will be randomized into 1 of 2 treatment arms (OPC 50 mg, or placebo) in a 1:1 ratio, and enter a 24-week placebo-controlled, parallel-group, double blind period. At the end of the double-blind period, subjects may enter an additional 1-year, open-label period, at the discretion of both the Investigator and subject, in which all subjects will be treated with OPC 50 mg. A Post-study Visit (PSV) will be performed approximately 2 weeks after the End of Study Visit (EOS) or Early Discontinuation Visit (EDV). Study treatment will be administered in combination with existing treatment of L-DOPA/DDCI.

Conditions

• Parkinson

Interventions

Type	Name	Description
DRUG	Opicapone 50 mg	Capsule, 50 mg, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI
DRUG	Placebo	Capsule of to matching placebo, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI

Timeline

• Start date: 2021-05-31
• Primary completion: 2023-01-11
• Completion: 2024-01-26
• First posted: 2021-07-27
• Last updated: 2025-03-12

Locations

1 site across 1 country: Bulgaria