Autoimmune encephalitis Nervous System Diseases
Conditions
Interventions
Patients will be randomized 1:1 to IVIG or placebo using random permuted blocks stratified by site, and time from symptom onset. Patients will receive 2 g/kg IVIG or placebo over 5 days. All patients
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/03/2024: 1. Adults (=16 years) with altered consciousness level AND/OR behavioural change AND/OR working memory deficit AND/OR psychiatric symptoms 2. Persisting for >24 hours and 24 hours and <3 months 3. In whom clinician thinks autoimmune encephalitis is the most likely diagnosis 4. CSF polymerase chain reaction (PCR) negative for HSV 1 and 2, and varicella zoster virus 5. CSF microscopy and culture-negative at 48 hours for organisms PLUS two or more of: 1. Seizures (not explained by previously known seizure disorder) OR new movement disorder 2. Cerebrospinal fluid (CSF) white blood cell count 6-1000/mm³ 3. Electroencephalogram consistent with encephalitis 4. Brain magnetic resonance imaging (MRI) or computer tomography (CT) changes consistent with encephalitis
Exclusion criteria
Exclusion criteria: 1. No other likely diagnosis 2. Current or recent (within last 6 months) treatment with IVIG 3. Contraindication to IVIG 4. Intolerance of corticosteroids 5. Recent history of gastric ulcers 6. CSF analysis not performed 7. CSF polymerase chain reaction (PCR) positive for any viruses 8. Brain imaging not performed 9. Alternative diagnosis on brain imaging (CT or MRI) 10. Known HIV infection 11. On steroids or other disease-modifying anti-inflammatory therapies 12. Not able to live independently prior to onset of condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery measured using the Glasgow Outcome Scale-Extended (GOSE) every 2 weeks for the first 3 months and then monthly until 12 months post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recovery measured using the Glasgow Outcome Scale-Extended (GOSE) at 3 months (all patients), then at 12 months and annually for the duration of the trial for patients who reach those timepoints 2. Neuropsychological outcomes measured using a standard battery of tests (Addenbrooke’s Cognitive Examination III, Weschsler Memory Scale version IV, Wechsler Adult Intelligence (WAIS) test version IV, Confrontational Naming Task, Trail Making Test Parts A and B, Test of Premorbid Functioning, Beck Depression Inventory, Beck Anxiety Inventory, and Perceived Deficits Questionnaire) as well as the Modified Rankin Scale, and The Liverpool Outcome Score. This will be administered at 12 months post-randomization. 3. Health utility and self-rated health measured using EuroQoL five dimension Scale (EQ5D5L) and European Brain Injury Questionnaire (EBIQ) at 3 months, then at 12 months and annually for patients who reach those timepoints 4. Clinical outcomes including adverse events, time to hospital discharge, use of additional immunotherapy rescue treatments, relapse, HDU/ITU admission, seizures, use of ventilator support, and mortality, measured using medical notes and assessment at clinical follow-up appointments at 2 weeks, 3 months and 12 months | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactPaula Foscarini-Craggs
Outcome results
None listed