Autoimmune EncephalitisPOTANCT05711563
Predicting and Monitoring Outcomes in Autoimmune Encephalitis
An observational study of Autoimmune Encephalitis, run by Royal College of Surgeons, Ireland.
Trial summary
Epilepsy is a disorder of the brain in which people have repeated seizures. Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Observational study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with probable or definite autoimmune encephalitis will be recruited via the Oxford Autoimmune Neurology Group in the UK and Beaumont Hospital in Ireland.
Who may be able to join
- AE participants over the age of 18 will be recruited if they meet the criteria for clinically probable or clinically definite Autoimmune Encephalitis as per Graus and colleagues 2016.
- Neurological Control participants undergoing lumbar puncture as part of clinical care for other, non-encephalitis disorders (e.g. for investigation of headache where meningitis or encephalitis is not detected, for investigation and treatment of idiopathic intracranial hypertension) in Beaumont hospital will be recruited.
Who cannot join
- AE participants
- Under 18 years of age
- Participants without AE or those with a definitive alternate diagnosis for presentation.
- Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
Trial locations and contacts
No sites are listed yet.
About this study
Epilepsy is a disorder of the brain in which people have repeated seizures.
Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria, by producing an army of proteins called 'antibodies' which go on to 'attack' healthy tissues.
Read more
Seizures in AE typically do not respond well to classic 'anti-seizure medications'. Instead, medications which suppress the immune system are used. These can have significant side-effects and some patients will still continue to have seizures or experience a recurrence of AE-related epilepsy despite treatment. It is difficult to accurately predict who will experience these outcomes.
This study aims to find ways of predicting and monitoring which people with AE are at greatest risk of these outcomes, so we can better direct them towards appropriate treatments. We will collect clinical information and samples of blood and cerebrospinal fluid (CSF, fluid surrounding the brain and spinal cord) from people with AE and 'control' participants with other neurological illnesses. Samples will be analysed for markers which may help predict or correlate with outcomes in AE and better understand this condition.
- Conditions
- Autoimmune Encephalitis
- Being tested
- Observational study
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune Encephalitis (Ireland) | Not described Receives: Other: Observational study | |
| Autoimmune Encephalitis (UK) | Not described Receives: Other: Observational study | |
| Other neurological controls | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
>50% improvement in seizure frequency over time
Measured: 1-3 years
Functional status
Modified Rankin score
Measured: 1-3 years
Secondary outcomes (10)
Cognitive ability
As measured by the Addenbrooke's Cognitive Examination.
Measured: 1-3 years
Clinical status
As measured by the Clinical Assessment of severity in Autoimmune Encephalitis.
Measured: 1-3 years
Mood/affect
Measured by the hospital anxiety and depression index
Measured: 1-3 years
Quality of life
EQ-5D-5L (By EuroQOL, not an abbreviation)
Measured: 1-3 years
Pain
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain interference short form A
Measured: 1-3 years
Fatigue
Fatigue Scale for Motor and Cognitive Funcitons
Measured: 1-3 years
Fatigue
Modified Fatigue and Impact Scale
Measured: 1-3 years
Sleep Quality
Pittsburgh Sleep Quality Index
Measured: 1-3 years
Impulsivity
Barratt Impulsivity Index
Measured: 1-3 years
Neuropsychiatric symptoms
Neuropsychiatric Inventory
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies 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
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711563
- Sponsor's protocol ID
- 212573289
- Acronym
- POTA
- Status last verified
- Jan 2023
- First submitted
- 30 Aug 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data or samples may (with consent) be shared in coded format with other ethically approved research studies, relating to disorders of the nervous system.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Monitoring Outcomes in Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT05711563
- Acronym / sponsor ID
- POTA / 212573289
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Feb 2023 (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.
Epilepsy is a disorder of the brain in which people have repeated seizures.
Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria, by producing an army of proteins called 'antibodies' which go on to 'attack' healthy tissues.
Seizures in AE typically do not respond well to classic 'anti-seizure medications'. Instead, medications which suppress the immune system are used. These can have significant side-effects and some patients will still continue to have seizures or experience a recurrence of AE-related epilepsy despite treatment. It is difficult to accurately predict who will experience these outcomes.
This study aims to find ways of predicting and monitoring which people with AE are at greatest risk of these outcomes, so we can better direct them towards appropriate treatments. We will collect clinical information and samples of blood and cerebrospinal fluid (CSF, fluid surrounding the brain and spinal cord) from people with AE and 'control' participants with other neurological illnesses. Samples will be analysed for markers which may help predict or correlate with outcomes in AE and better understand this condition.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autoimmune Encephalitis (Ireland) | – | Other: Observational study |
| Autoimmune Encephalitis (UK) | – | Other: Observational study |
| Other neurological controls | – | Other: Observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with probable or definite autoimmune encephalitis will be recruited via the Oxford Autoimmune Neurology Group in the UK and Beaumont Hospital in Ireland.
Key inclusion criteria (2 listed)
- AE participants over the age of 18 will be recruited if they meet the criteria for clinically probable or clinically definite Autoimmune Encephalitis as per Graus and colleagues 2016.
- Neurological Control participants undergoing lumbar puncture as part of clinical care for other, non-encephalitis disorders (e.g. for investigation of headache where meningitis or encephalitis is not detected, for investigation and treatment of idiopathic intracranial hypertension) in Beaumont hospital will be recruited.
Key exclusion criteria (4 listed)
- AE participants
- Under 18 years of age
- Participants without AE or those with a definitive alternate diagnosis for presentation.
- Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
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 |
|---|---|---|
| Observational studyObservational study | Other | Autoimmune Encephalitis (Ireland), Autoimmune Encephalitis (UK), Other neurological controls |
Primary outcome
Seizure frequency
Time frame: 1-3 years
>50% improvement in seizure frequency over time
Functional status
Time frame: 1-3 years
Modified Rankin score
10 secondary outcomes
Cognitive ability
Time frame: 1-3 years
Clinical status
Time frame: 1-3 years
Mood/affect
Time frame: 1-3 years
Quality of life
Time frame: 1-3 years
Pain
Time frame: 1-3 years
Fatigue
Time frame: 1-3 years
Fatigue
Time frame: 1-3 years
Sleep Quality
Time frame: 1-3 years
Impulsivity
Time frame: 1-3 years
Neuropsychiatric symptoms
Time frame: 1-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Yes. Data or samples may (with consent) be shared in coded format with other ethically approved research studies, relating to disorders of the nervous system.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by Royal College of Surgeons, Ireland.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Kelly, MB BCh BAO, MSc, MRCP (+353 1 809 2210, markkelly22@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: 1-3 years). The study lists 2 primary outcomes in all. 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 Feb 2023.