Epi-IRISNCT07903168

Why Do People With Epilepsy Get More Infections?

StatusRecruiting

PhaseNot specified

SponsorUniversity of Aberdeen

Primary completionMay 2038 (estimated)

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 5, 2026 Recruitment opened
- Start date changed from estimate of Nov 2026 to Nov 4, 2026
Minor Oct 29, 2026 Study description expanded, about 7 words
Oct 21, 2026 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Infections

Timeframe: During a 10 year period from the time of enrolment

Secondary (4)

Blood immune system parameters

Experimental laboratory tests

Prediction of infection

Validated algorithm

Arms and interventions

Exposed

Individuals taking antiseizure medications

Unexposed

Individuals not taking antiseizure medications

Drugs: Antiepileptic Drug

Sites

1 site in 1 country

Institute of Applied Health Sciences, University of AberdeenAberdeen, United Kingdom

About this trial

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.

Trial details

Enrollment: 500 participants (estimated)
Started: Nov 4, 2026
Study completion: May 2038 (estimated)
Eligibility: 16 and older, all sexes
Design: Observational
Oversight: No data monitoring committee
Conditions: Epilepsy, Immune System Diseases, Infections, Antiepileptic Drugs, Infection, Immune Dysfunction
Official title: Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy
First posted: Oct 29, 2026
Registry updated: Nov 10, 2026
Last verified: Nov 2026

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