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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Opicapone; Drug: Levodopa (L-DOPA) + Standard care

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47UY
      • Norfolk&Norwich University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study plans to recruit approximately 100 elderly PD patients from neurology clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Standard of care (including L-DOPA) + starting opicapone	Drug: Opicapone; Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.; Other Names: Ongentys; 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.
Cohort 2; Standard of care (including L-DOPA)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients having at least one Adverse Event (AE)	All AEs reporting	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Catechol O-Methyltransferase Inhibitors; Levodopa; Opicapone
• Other Study ID Numbers: BIA-91067-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No