EP-SKIN
Research type
Research Study
Full title
Non-invasive Monitoring of Antiepileptic Drug Levels – A Pilot Study
IRAS ID
299959
Contact name
Katie Longman
Contact email
Sponsor organisation
University of Surrey
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
There are currently >20 antiepileptic drugs (AEDs) licenced in the UK. Choice of AEDs depends on the epilepsy syndrome, seizure type, concomitant medication, co-morbidities, age and sex. Control of epilepsy and prevention of seizures requires maintenance of an effective dose of one or more AEDs. An adjustment in the dose is often necessary to meet the individual optimal concentration for the patient. The failure of the dose optimisation can lead to significant adverse effects.
Therapeutic drug monitoring (TDM) has been applied widely to assist clinical management and achieve optimal clinical outcomes for people with epilepsy. In the UK, people with epilepsy are monitored regularly to ensure that the medication is working and that the patients are adhering to the treatment regime. There are currently no laboratory markers for clinical efficacy, adherence or toxicity of AEDs. Moreover, there are no rapid tests for AEDs.
AED TDM has been especially useful since AED concentration in plasma correlates better with clinical effects compared to the AED dose. Moreover, the toxicity can be difficult to assess from clinical grounds, yet it is evident from drug concentrations. AED TDM is essential to guide the dosing for individuals as AEDs are subject to substantial pharmacokinetic variability. Plasma and serum are the matrices of choice for AED TDM.
Although the value of TDM is acknowledged by many medical professionals, testing from blood requires close personal contact, and this is not practical in a pandemic setting. Saliva is a less invasive approach, but carries the disadvantage that some patients are unable to produce sufficient volume.
Alternative approaches to AED TDM aim to be explored in this study via skin sampling (fingerprints and sebum). Such techniques benefit from quick and easy sampling procedures, ideal where collection of blood and saliva is difficult and where the current pandemic limits clinic visits.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0749
Date of REC Opinion
24 Dec 2021
REC opinion
Further Information Favourable Opinion