NCT04986995

OpicApone Sleep dISorder

Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (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 To investigate in an exploratory manner 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 sleep disorders

Detailed description

This is an open-label, single-arm, multi-centre, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated sleep disorders. The study consists of a 1-week screening period, a 6-week treatment period and 2 weeks of follow-up period. Expected duration of treatment for the individual patient is up to 6 weeks.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone	Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

Timeline

• Start date: 2021-06-09
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2021-08-03
• Last updated: 2025-03-12

Locations

1 site across 1 country: Portugal