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

BIAL

Status

Completed

Conditions

Parkinson Disease

Treatments

Drug: Opicapone

Drug: Levodopa (L-DOPA) + Standard care

Study type

Observational

Funder types

Industry

Identifiers

NCT03959540

BIA-91067-402

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
Patient with age >=75 years at enrolment
Patient with end-of-dose motor fluctuations suitable for additional treatment optimization

Exclusion criteria

Patient concurrently participating in any clinical trial
Patient who used tolcapone or opicapone previously
For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
Patient with any contraindications to Ongentys use
Patient with any concomitant medical condition that could interfere with study assessments