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

Parkinson Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959540
• Other study ID #: BIA-91067-402
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: May 11, 2021

Study information

• Verified date: October 2021
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Opicapone
Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
• 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.

Locations

Country	Name	City	State
United Kingdom	Norfolk&Norwich University Hospitals	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having at least one Adverse Event (AE)	All AEs reporting	through study completion, an average of 1 year
Secondary	Clinical Global Impression of Improvement (CGI-I)	hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).	at Follow-up visit at 1, 3, 6, 9, 12 months
Secondary	Parkinson Disease Questionnaire (PDQ-8)	hange of score from baseline at each follow-up visit (from 0=good health to 100=poor health).	at baseline, Follow-up visit at 6,12 months
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)	change from baseline at each follow-up visit for each of the 4 sections and for the total score (from 0=no disability to 199=total disability).	at baseline, Follow-up visit at 6,12 months
Secondary	Montreal Cognitive Assessment (MoCA)	change from baseline at each follow-up visit (30-point test; score >26 is normal).	at baseline, Follow-up visit at 6,12 months
Secondary	Patients' Global Impressions of Change (PGI-C)	Percentage of patients for each item at each follow-up visit (from 1=very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment).	at Follow-up visit at 1, 3, 6, 9, 12 months