CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 144 enrolled
Drug / intervention
Opicapone 50 mg +1 moredrug
Likely dose
Opicapone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04986982
NCT04986982Phase 4Completed
CompareCT.gov

Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain.

Bial - Portela C S.A.·interventional·Posted Aug 3, 2021·Updated Mar 28, 2025

In Brief

A Phase 4 clinical trial evaluating Opicapone 50 mg and Placebo for Parkinson Disease. Completed, enrolled 144 participants across 1 site.

Detailed Summary

The aim of this study is to investigate the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated pain

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 3, 2021
Enrollment StartFeb 25, 2021
Primary CompletionFeb 16, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.9 years ago

Interventions

Opicapone 50 mgdrug

Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

Placeboother

Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI