Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT02714959
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Clinical diagnosis of autoimmune encephalitis
* Positive for autoantibody (serum and or CSF) : NMDAR, anti-leucine-rich glioma inactivated-1(LGI-1), contactin-associated protein-like 2 (CASPR2), α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) 1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/collapsing response mediator protein 5 (CRMP5), -amphiphysin, or glutamic acid decarboxylase (GAD)
* Refractory to first-line (high-dose steroid or intravenous immunoglobulin) and second line (rituximab or cyclophosphamide) immunotherapy
* Written informed consent form.
Exclusion Criteria:
* low hemoglobin \<8.0 g/dL, absolute neutrophil count\<1600/mm3, lymphocytes \<600/mm3, platelets \<140,000/mm3
* heart failure (≥ grade III NYHA), hepatic insufficiency (aspartate amino transferase \>200 IU/L, amino alanine transferase, \>200 IU/L), or lung failure
* Positive for HIV serology, active hepatitis B
* Significant abnormality in chest X-ray other than these linked to the diseases under investigation
* Infection
* Other progressive neurological degenerative disease.
* Poor venous access not allowing repeated blood tests
* pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT02714959
Study Brief:
Protocol Section:
NCT02714959