Clinical trial NCT03959540: Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 39
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study plans to recruit approximately 100 elderly PD patients from neurology clinics

Brief 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

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients having at least one Adverse Event (AE)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: at Follow-up visit at 1, 3, 6, 9, 12 months
measure: Parkinson Disease Questionnaire (PDQ-8)
timeFrame: at baseline, Follow-up visit at 6,12 months
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: at baseline, Follow-up visit at 6,12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: at baseline, Follow-up visit at 6,12 months
measure: Patients' Global Impressions of Change (PGI-C)
timeFrame: at Follow-up visit at 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk&Norwich University Hospitals
state: Norfolk
Study officials:
References: