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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Opicapone
* Drug: Levodopa (L-DOPA) + Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Standard of care (including L-DOPA) + starting opicapone | Drug: Opicapone<br>* Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.<br>* Other names: Ongentys;Drug: Levodopa (L-DOPA) + Standard care<br>* Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.<br>|
| Cohort 2<br>Standard of care (including L-DOPA) | Drug: Levodopa (L-DOPA) + Standard care<br>* Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.<br>|

What is the study measuring?
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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 |