PD chart review_ version 1.0
Research type
Research Study
Full title
Healthcare resource utilisation in patients with Parkinson’s disease after treatment with entacaponeand opicapone
IRAS ID
260316
Contact name
Christopher Kobylecki
Contact email
Sponsor organisation
Bial Pharma UK Ltd.
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Parkinson disease (PD) is a common chronic, slowly progressive neurodegenerative incurable disorder with clinical features typically consisting of motor and non-motor symptoms, which have a devastating effect on the quality of life of the patient. At the moment, there is only symptomatic treatment available, as there is little evidence about neuroprotective or disease-modifying treatment. Levodopa is the most effective treatment for Parkinson’s to decrease ‘OFF’ time (when patients are symptomatic) and increase ‘ON’ time (when patients’ symptoms are controlled), but higher doses lead to increased side effects, such as levodopa-induced dyskinesia and motor complications. Regarding the impact on health services, PD is associated with substantial direct healthcare costs to the NHS and indirect costs to the patient and society. A multi-centre, non-interventional pilot study via retrospective chart review is designed with the aim to assess the healthcare resource utilization in patients before (when on entacapone therapy) and after receiving opicapone, in a real world setting. The source population for this study pilot is comprised of adult (≥ 18 years old) patients with Parkinson’s disease. Up to 5 sites in the UK will be considered initially for this study pilot. Investigators are physicians specializing in the management of patients with Parkinson’s disease. The study pilot period is defined retrospectively as 1st October 2016 – 31st January 2019. The study will be descriptive in nature; therefore, no hypothesis will be tested. As such, no formal sample size estimation is required. It is expected that up to 30 patients will be found to be eligible for the study across the UK study centres during the study period.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0286
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion