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NCT07903168Not yet recruiting

Why Do People With Epilepsy Get More Infections?

Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
21 Oct 2026
Start date
1 Nov 2026
Primary completion date
31 May 2038
Lead sponsor
University of Aberdeen
Diseases
Epilepsy
NCT number
NCT07903168

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 1 Nov 2026 to the primary completion date, 31 May 2038
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute symptomatic seizure(s) without previous or subsequent unprovoked seizure(s) (e.g. due to head trauma, severe infection, significant electrolyte abnormality, alcohol withdrawal) would be an exclusion from the first seizure/epilepsy group.
  • Migraine control group:
    • Receiving treatment with antiseizure medications; or
    • Receiving immunosuppressive\* treatment for another condition; or
    • Medical history of single unprovoked seizure or epilepsy
    • Exclusion due to immunosuppression increasing risk of immune dysfunction. Immunosuppression is not an exclusion criterion for first seizure/epilepsy groups as immunosuppression will be used as a variable for other analyses, including risk prediction analyses.

Other illness

  • Functional (non-epileptic) seizures without epileptic seizures or migraine. If the patient has both epileptic and functional seizures, or migraine and functional seizures, they would be eligible for inclusion, provided they meet the other criteria.
  • First seizure group:
    • Those taking or are planned to be started on antiseizure medication(s)
  • New diagnosis of epilepsy group:
    • Those not planned to be started on an antiseizure medication
    • Those taking, or are planned to be started on, two or more antiseizure medications
    • Those already taking an antiseizure medication at the time of their new diagnosis of epilepsy
  • Established epilepsy group:
    • Those taking, or are planned to be started on, two or more antiseizure medications
    • Those not taking an antiseizure medication, even if planned to be started on an antiseizure medication

Who the study is looking for

  • Adults aged 16 or over
  • Resident in an area covered by NHS Grampian neurology service
  • Individuals with:
    • A diagnosis of first unprovoked (or reflex) seizure; or
    • A new diagnosis of epilepsy (at least two unprovoked (or reflex) seizures occurring more than 24 hours apart)); or
    • Established diagnosis of epilepsy; or
    • A diagnosis of migraine
  • Able to give informed consent to participate or, if lacking capacity, a reliable Welfare Guardian/Welfare Attorney/Nearest Relative can give consent on behalf of the participant.
    • Definition of established epilepsy in this context:
  • The individual was diagnosed with epilepsy prior to the consultation at which the clinician referred them to the research team; or
  • When a potential participant is identified from a previous clinic consultation, they already have a diagnosis of epilepsy.

Age in the registry: 16 years to - · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.