Medium-term Effects of Treatments in Autoimmune Encephalitis (NCT07133113) | Clinical Trial Compass
RecruitingNot Applicable
Medium-term Effects of Treatments in Autoimmune Encephalitis
France200 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how well the initial treatment works for autoimmune encephalitis types like NMDAR, LGI1, and CASPR2 — does my specific antibody type match one of those, and would that make this trial worth discussing for my situation?
2Since the main thing this trial is measuring is whether the first round of treatment fails, can you explain what 'treatment failure' would mean for me and what would happen next if that occurs?
3This trial is listed as 'Phase NA,' which suggests it's more of an observational or registry study rather than testing a new drug — does that mean I would still receive standard care, and what exactly would be different about my treatment compared to not being in the trial?
4Given that autoimmune encephalitis can move quickly, how soon would I need to decide whether to participate, and would joining this study delay or change any treatment I might need to start right away?
5Are there other treatment approaches or clinical trials for my specific antibody type that you think I should weigh against participating in this observational study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Failure of the initial treatment protocol
Timeframe: At baseline and 4 months after the initiation of therapy