Treatment of autoimmune encephalitis in adults with intravenous immunoglobuli

Phase 3

• Conditions: Autoimmune encephalitis; Nervous System Diseases

• Registration Number: ISRCTN69615004
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-18
• Last Update Posted: 18 March 2024
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 356

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 <12 months but no more than 3 months since diagnosis
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 (including normal scan)

Previous inclusion criteria:
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 <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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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