Medium-term Effects of Treatments in Autoimmune Encephalitis

Recruiting

• Conditions: NMDAR Autoimmune Encephalitis; LGI1 Antibody Associated Encephalitis; CASPR2-Antibody; IgLON5; GAD65; GFAP

• Registration Number: NCT07133113
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab, cyclophosphamide, tocilizumab, others), and may be used in association or sequentially. There is no standard practice, and initial treatment protocol may consist in first-line alone, first-line with rituximab, or first-line with dual immunosuppression (rituximab and cyclophosphamide). Absence of clear response to initial treatment in the first 4 to 6 weeks may indicate undertreatment and is generally followed by treatment escalation, mostly to dual immunosuppression. However, as the frequency of non-responders to initial treatment is unknown, it is still unclear whether dual immunosuppression should be offered to all patients from inception.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP
• Untreated or with a decision to treat within the previous 30 days.

Exclusion Criteria

• Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his/her clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure of the initial treatment protocol	At baseline and 4 months after the initiation of therapy	Failure of the initial treatment protocol, reflected by the decision to escalate treatment between V1 and V2. Treatment escalation is defined as the addition of one or more second-line treatments more than 30 days after the start of the initial treatment.

Trial Locations

Locations (1)

Hospices Civil de Lyon; 🇫🇷 Bron, France