Retrospective notes review of patients on DUODOPA
Research type
Research Study
Full title
A retrospective notes review to characterise the UK patient population treated with levodopa/carbidopa intestinal gel (LCIG)
IRAS ID
135453
Contact name
K Ray Chaudhuri
Contact email
Sponsor organisation
AbbVie Ltd
Research summary
This is a UK-based multi-centre retrospective observational study to characterise the UK patient population treated with levodopa/carbidopa intestinal gel (Duodopa). Duodopa is used in advanced Parkinson's Disease(PD) - a population that is not clearly defined in the UK. In the UK the current prevalence of all Parkinson's Disease is 127,000 and advanced Parkinson's Disease is thought to consist of approximately 10% of this group.In the UK, Duodopa is seen as a specialist medicine and only a small proportion of this population has been treated with it. To date this population has not been characterized and it is believed that there may be pronounced differences within the group of patients that have been treated.
The study will involve retrospective review of 100-150 patients' medical records from 15 centres to describe the population of patients that have received Duodopa since its introduction in 2007 and to evaluate the variation between the centres. Outcomes will include length of treatment, reasons for discontinuation, impact on patient factors and use of other PD medication, patient characteristics associated with duration of treatment, regional differences in treatment duration, variations in the population intitiated on duodopa, the treatment duration and the reason for discontinuation over the 6 years since launch. The sample constitutes over half of the patient population treated with Duodopa at these centres during the last 6 years. Data will be collected by members of the routine care team and provided to researchers for analysis in anonymised-coded form.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
13/LO/1388
Date of REC Opinion
9 Sep 2013
REC opinion
Favourable Opinion