NMDA Satralizumab (Autoimmune Encephalitis) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if a drug called satralizumab (the study drug) is a safe and effective option for people with autoimmune encephalitis.
NMDAR (N-Methyl-D-Aspartate Receptor) Encephalitis
Who Can Participate in the Study?
Children and adults ages 12+ who:
- Are diagnosed with NMDAR encephalitis or probable NMDAR encephalitis
- Have had symptoms for fewer than 9 months before joining the study
For more information, contact the study team at lynn.rodgers@duke.edu.
What is Involved?
If you or your child choose to join this study, you/they will get a random assignment (like a coin flip) to either:
- Get the study drug; OR
- Get a placebo (inactive substance with no drug in it)
The study drug and placebo are given as injections (shots) every 4 weeks. The study is blinded for one year, which means that neither you/your child nor the research team will know if you/they are getting the study drug or a placebo. At the end of the blinded period, there will be an extension period. During this period, you/your child will have the choice to begin taking the study drug on an unblinded basis or to continue participating as a blinded participant.
You/your child will have various tests done during your time in the study. Estas pruebas incluyen:
- Electroencephalograms or EEGs (a test that measures electrical activity in the brain)
- Electrocardiograms or ECGs (a test that records electrical signals in the heart)
- Extracción de sangre
- Exámenes físicos