An observational study in Epilepsy, Antiepileptic Drugs and Infection, sponsored by University of Aberdeen. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Aberdeen · Observational
People with epilepsy are predisposed to having seizures ("fits"), where abnormal electrical activity in the brain disrupts normal brain functioning. It is a common condition with around 1% of the population of Scotland having this condition. They are treated with anti-seizure medications, drugs which reduce the chance of having seizures.
Unfortunately, people with epilepsy are more likely to have severe infections than those without epilepsy and this is known to increase risk of seizures. The reasons for more severe infections in people with epilepsy are unclear, but one factor may be that anti-seizure medications impair the function of the body's immune system, which fights infection. The investigators' previous work looking at residents in the North-East of Scotland showed a link between these medications and risk of infection.
The investigators plan to study people being started on antiseizure medications (ASMs) with a new diagnosis of epilepsy and those already on ASMs with an established diagnosis of epilepsy in NHS Grampian. The investigators will compare with people not taking ASMs in a group of people with a single seizure and in a group of people with migraine.
The investigators will investigate immune function and infection risk with more-detailed information about individual's background, their seizures/epilepsy, other health conditions, and blood tests. The investigators will then do laboratory experiments to determine how ASMs may impair the immune system by looking at the function of types of white blood cells that play an important part in immune functioning.
The investigators also wish to develop statistical tools which can identify an individual's risk of infection when starting ASMs, based on their demographic, medical and social characteristics, to target closer monitoring/changes in treatment to those with higher risk.
This research will allow healthcare professionals to provide better individualised care in terms of which medication to use for treatment, what doses to use and whether blood tests to screen for impaired immune function would be helpful. The aim is that this will lead to reduced risk of infections in people with epilepsy, resulting in better outcomes in this condition.
Background:
Epilepsy is a common neurological condition affecting 1% of the population and is associated with a 2.6-fold increased mortality risk, partly due to infection-related deaths. The investigators previously showed that anti-seizure medications (ASMs) are associated with abnormal immune function (hypogammaglobulinemia, lymphopenia, and neutropenia) and increased infection risk, but further work is needed to understand this risk and whether it can be reduced.
Aims:
Protocol/methodology:
The investigators will recruit a cohort of approximately 500 participants: 100 new epilepsy cases and 100 established epilepsy cases (treated with ASMs) and 200-300 first seizures and 0-100 people with migraine (not treated with ASMs) and follow them for 10 years. This will result in an initial cohort of approximately 200 individuals treated with ASMs (new and established epilepsy) and 300 not treated with ASMs (between first seizure and migraine). Using this cohort, the investigators will investigate changes in immune parameters (hypogammaglobulinemia, lymphopenia, neutropenia) in people treated with ASMs. The investigators will then investigate the frequency of infections. These analyses will expand on the investigators' previous work by adjusting for co-morbidities and studying specific types of infection, such as opportunistic infections. The investigators will use routinely collected data to support the information gathered from patients during the study, and to validate the use of this for determining diagnosis of epilepsy and seizure frequency.
The investigators will investigate potential mechanisms of immune system dysfunction with ASMs with in vitro studies of innate immune system activity, including phagocytosis assays, killing assays, and viability assays in cultured macrophages/neutrophils with and without ASMs
The investigators will then develop a prognostic model to identify people taking ASMs who are at high risk of infection who may need monitoring of immune parameters.
Expected outcomes/benefits:
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 500 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →University of Aberdeen is the lead sponsor of 176 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Resident in an area covered by NHS Grampian neurology service.
Potential participants will have either been reviewed by the neurology team as an inpatient or outpatient.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals with:
Definition of established epilepsy in this context:
Exclusion Criteria:
First seizure group:
a) Those taking or are planned to be started on antiseizure medication(s)
New diagnosis of epilepsy group:
Established epilepsy group:
Migraine control group:
Medical history of single unprovoked seizure or epilepsy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals taking antiseizure medications
Drug: Antiepileptic Drug
Individuals not taking antiseizure medications
Antiseizure medications prescribed as routine care
Also known as: Antiseizure medication
Infections
Clinically significant rates of infection (community antimicrobial prescriptions or hospital admissions with infection)
Time frame: During a 10 year period from the time of enrolment
Blood immune system parameters
Abnormal level of blood immune system parameters (white blood cell counts, immunoglobulins, lymphocyte subsets)
Time frame: During a 10 year period from the time of enrolment
Experimental laboratory tests
In vitro macrophage and/or neutrophil functioning with exposure to common ASMs (carbamazepine, lamotrigine, levetiracetam, phenytoin, sodium valproate)
Time frame: Blood obtained during enrolment and/or 6 months after enrolment
Prediction of infection
A prognostic model (a statistical tool) that can be used to predict infection frequency in those being started on ASMs.
Time frame: During a 10 year period from the time of enrolment
Validated algorithm
Validated algorithms using routinely collected healthcare data to i) identify diagnoses of epilepsy; ii) measure seizure recurrence and iii) good seizure control.
Time frame: During a 10 year period from the time of enrolment
Started Nov 2026 (actual). Primary completion is estimated for May 2038, 138 months after the start.
Of 193 non-industry observational studies under Epilepsy, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 179. This study's planned 138 months is above that.
Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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