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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT03959540
• Date of registration: 23/04/2019
• Prospective Registration: Yes
• Primary sponsor: Bial - Portela C S.A.
• Public title: Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
• Scientific title: 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
• Date of first enrolment: April 28, 2020
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03959540
• Study type: Observational

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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



Age minimum: 75 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Opicapone

Drug: Levodopa (L-DOPA) + Standard care

Primary Outcome(s)

Percentage of patients having at least one Adverse Event (AE) [Time Frame: through study completion, an average of 1 year]

Secondary Outcome(s)

Montreal Cognitive Assessment (MoCA) [Time Frame: at baseline, Follow-up visit at 6,12 months]

Clinical Global Impression of Improvement (CGI-I) [Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months]

Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: at baseline, Follow-up visit at 6,12 months]

Parkinson Disease Questionnaire (PDQ-8) [Time Frame: at baseline, Follow-up visit at 6,12 months]

Patients' Global Impressions of Change (PGI-C) [Time Frame: at Follow-up visit at 1, 3, 6, 9, 12 months]

Secondary ID(s)

BIA-91067-402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors