Adjunctive ASM RWE study
Research type
Research Study
Full title
A 12-month, prospective, observational study in adult patients with focal onset seizures who are treated with adjunctive ASM in real world setting.
IRAS ID
332698
Contact name
Michael Kinney
Contact email
Sponsor organisation
Angelini Pharma SpA
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
The CENOP study is an observational, prospective, multi centre, study that is being ran in the UK, France, Italy, Germany, the Nordics, Austria and Spain.
The study collects data on epileptic patients from their routine clinic appointments. These patients are affected by focal onset seizures (FOS) who are already eligible to start treatment with any adjunctive anti-seizure medication (ASM) in a real world setting so that the effectiveness and safety of adjunctive ASM therapy can be assessed.
The question the study is looking to answer is to describe the effectiveness of adjunctive anti-seizure medication therapy on the clinical response, safety, and quality of life of patients affected by focal onset seizures.
Eligible patients have to be 18years or older and a total of 30 sites across the above-mentioned countries will be opened for the study with the UK sites being NHS organisations specialising in neurological issues such as epilepsy.
The study will run for 12months in total.REC name
Wales REC 5
REC reference
23/WA/0234
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion