NCT04986982

OpiCapone Effect on Motor Fluctuations and pAiN

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated pain. The study consists of a 1-week screening period, a 24-week double-blind treatment period and 2 weeks of follow-up period. The duration of treatment for the individual patient is expected to be up to 24 weeks.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone 50 mg	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
OTHER	Placebo	Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

Timeline

• Start date: 2021-02-25
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2021-08-03
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United Kingdom