ECLIPSE
Research type
Research Study
Full title
A prospective observational clinical study to investigate the association between BioEP and self-reported seizure control during anti-seizure medication (ASM) titration.
IRAS ID
331371
Contact name
Rohit Shankar
Contact email
Sponsor organisation
Neuronostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
The accurate diagnosis and prognosis of epilepsy represents a significant unmet medical need. If a patient is diagnosed with epilepsy, they will be commenced on anti-seizure medication (ASMs). However, the process of administering ASMs is slow, as it needs to be titrated over a number of months to achieve an effective dose, with minimal side effects. Once more, a patient can spend months trialling one medication to find no positive anti-seizure effect of experience multiple side effects. There are currently no such robust markers that indicate treatment response to ASMs.
Neuronostics have developed a Biomarker called BioEP. They have worked in partnership with neurologists in the UK and Australia and have developed pilot data that demonstrates changes in the BioEP score from sequential EEGs in response to ASMs. This is an exciting development which we aim to build on by expanding on this evidence to demonstrate clinical validity and utility. If clinically validated this represents the first quantitative prognostic biomarker to demonstrate direct relationship between itself and ASM treatment response evaluated from routinely collected clinical data. If successful, this would, in the UK alone, enhance the lives and ASM medication management strategies of over 250,000 people with poorly controlled seizures
We plan to perform a multisite prospective clinical study to investigate the relationship between seizure type and frequency and BioEP during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy. The study will consist of a cohort of adult patients who present to first seizure clinics.
This is a 3 year study – 24 months recruitment, 6month follow up and 6 months analysis
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0109
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion