EpilepsyEpi-IRISNCT07903168
Why Do People With Epilepsy Get More Infections?
An observational study of Epilepsy and Antiepileptic Drugs, run by University of Aberdeen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Antiepileptic Drugs, Infection
- What is being tested?
- Antiepileptic Drug
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- 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.
- 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
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- 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
- 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.
About this study
Official title: Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy
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.
Read more
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.
Read the detailed description
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:
- To clarify the effects of ASM on blood immune parameters
- To establish whether ASMs are associated with increased infection rates
- To explore potential mechanisms of immune dysfunction with commonly used ASMs
- To develop predictive models for infection risk based on clinical and laboratory data
- To develop and validate algorithms using routinely collected healthcare data to determine diagnosis of epilepsy, recurrence of seizure and good seizure control.
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:
- A better understanding of infection risk in those treated with ASMs.
- Ability to identify those at high infection risk and intervene to reduce infection-related morbidity/mortality with screening, changing ASMs, or interventions directed at the mechanisms.
- Conditions
- Epilepsy, Antiepileptic Drugs, Infection, Immune Dysfunction
- Being tested
- Antiepileptic Drug
- Keywords
- Epilepsy, Antiseizure medications, Infections, Immune dysfunction
- Medical subject headings
- Epilepsy, Infections, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiepileptic DrugDrug
Also called Antiseizure medication
Antiseizure medications prescribed as routine care
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Individuals taking antiseizure medications Receives: Drug: Antiepileptic Drug | |
| Unexposed | Individuals not taking antiseizure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infections
Clinically significant rates of infection (community antimicrobial prescriptions or hospital admissions with infection)
Measured: During a 10 year period from the time of enrolment
Secondary outcomes (4)
Blood immune system parameters
Abnormal level of blood immune system parameters (white blood cell counts, immunoglobulins, lymphocyte subsets)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: During a 10 year period from the time of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2038 (estimated)
- Study completionMay 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903168
- Sponsor's protocol ID
- 26/SS/0081-IRAS-367495
- Other IDs
- GCA25219, 2-006-26
- Acronym
- Epi-IRIS
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy
- ClinicalTrials.gov ID
- NCT07903168
- Acronym / sponsor ID
- Epi-IRIS / 26/SS/0081-IRAS-367495
- Conditions
- Epilepsy, Antiepileptic Drugs, Infection, Immune Dysfunction
- Keywords
- Epilepsy, Antiseizure medications, Infections, Immune dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2038 (estimated)
- Study completion
- May 2038 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To clarify the effects of ASM on blood immune parameters
- To establish whether ASMs are associated with increased infection rates
- To explore potential mechanisms of immune dysfunction with commonly used ASMs
- To develop predictive models for infection risk based on clinical and laboratory data
- To develop and validate algorithms using routinely collected healthcare data to determine diagnosis of epilepsy, recurrence of seizure and good seizure control.
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:
- A better understanding of infection risk in those treated with ASMs.
- Ability to identify those at high infection risk and intervene to reduce infection-related morbidity/mortality with screening, changing ASMs, or interventions directed at the mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: Antiepileptic DrugIndividuals taking antiseizure medications |
| Unexposed | – | –Individuals not taking antiseizure medications |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- Adults aged 16 or over
- Resident in an area covered by NHS Grampian neurology service
- Individuals with:
- 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.
- The individual was diagnosed with epilepsy prior to the consultation at which the clinician referred them to the research team; or
Key exclusion criteria (16 listed)
- 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.
- 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.
- First seizure group:
- New diagnosis of epilepsy group:
- Established epilepsy group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiepileptic DrugAlso: Antiseizure medicationAntiseizure medications prescribed as routine care | Drug | Exposed |
Primary outcome
Infections
Time frame: During a 10 year period from the time of enrolment
Clinically significant rates of infection (community antimicrobial prescriptions or hospital admissions with infection)
4 secondary outcomes
Blood immune system parameters
Time frame: During a 10 year period from the time of enrolment
Experimental laboratory tests
Time frame: Blood obtained during enrolment and/or 6 months after enrolment
Prediction of infection
Time frame: During a 10 year period from the time of enrolment
Validated algorithm
Time frame: During a 10 year period from the time of enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Antiepileptic Drugs, run by University of Aberdeen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infections (time frame: During a 10 year period from the time of enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.