NCT03959540

Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting

Detailed description

This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment. PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts: * Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone * Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment. This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone	Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
DRUG	Levodopa (L-DOPA) + Standard care	Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2019-05-22
• Last updated: 2021-10-04

Locations

1 site across 1 country: United Kingdom