BIAL EON Observational Study in the Elderly Patients
Research type
Research Study
Full 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
IRAS ID
263492
Contact name
Vaclav Dostal
Contact email
Sponsor organisation
BIAL - Portela & C.ª, S.A.
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study is a multinational, multicentre, prospective non-interventional study in elderly patients with Parkinson’s Disease. Approximately 100 patients with Parkinson’s Disease will be recruited by specialists from approximately 37 sites in 5 European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment. Patients with end-of-dose motor fluctuations suitable for additional treatment optimisation will be included and split into 2 cohorts: (a) Cohort 1: 50 patients who take the standard of care (including L-DOPA) and who will start Opicapone; (b) Cohort 2: 50 patients who receive only the standard of care (including L-DOPA but without Opicapone), as prescribed per routine clinical practice.
The study will include prospective data collection from the date of enrolment and key historical data from medical charts. Data will be collected at baseline, 1 month, 3 months, 6 months, 9 months and 12 months after enrolment and will be aligned with routine clinic visits. A remote follow-up visit via telephone will be also conducted at 1 or 2 weeks after the last visit (12 months following enrolment or Early Discontinuation Visit [EDV]).
Due to the difficulty in recruiting elderly patients in studies, recruitment could be stopped at one year OR when 75% of patients are recruited. A minimum of 30 patients per cohort will be required. Furthermore, if by the day the 50th recruited patient would reach 6 months of follow-up, the discontinuation rate has been >=30% at the 6 month-mark for the first 50 patients, then the duration of the follow-up will be reduced to 6 months for ALL the patients.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0209
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion