๐ฌIn plain words
What the trial is, and whether it could suit you
Based on the records of traditional Chinese medicine, CBS has the functions of purifying the heart, eliminating phlegm, stimulating bile secretion, and soothing the nerves. It has the ability to alleviate fever, coma, delirium, epilepsy, convulsions in youngsters, dental caries, throat swelling, mouth ulcers, carbuncle, and furuncle.
Encephalitis is a neurological condition characterized by widespread or multiple inflammation of brain tissue. The causes of encephalitis are many and can stem from infectious organisms or be induced by autoimmune reactions, the latter being referred to as autoimmune encephalitis (AE). The yearly occurrence rate of encephalitis is 12.6 per 100,000 individuals. Among these cases, approximately 40-50% are caused by infectious factors, whereas 20-30% are attributed to autoimmune encephalitis (AE). The development of viral encephalitis involves the direct invas
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Subjects must meet the following eligibility criteria at screening to participate in this study.
1.1 Inclusion criteria for subjects with autoimmune encephalitis (hereinafter referred to as AE) of all subtypes 1.1.1 Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.
1.1.2. Tumors or malignancies can be reasonably excluded before the baseline visit (randomization), and screening guidelines for thymoma, teratoma, and malignant tumors should be followed.
1.1.3. Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years old (inclusive).
1.1.4. Meet the diagnosis of AE (according to the Chinese Autoimmune Encephalitis Diagnosis and Treatment Expert Consensus 2022 Edition): A. Clinical manifestations: acute or subacute onset (\<3 months), with one or more of the following neurological and psychiatric symptoms or clinical syndromes.
* a. Limbic system symptoms: recent memory loss, epileptic seizures, mental and behavioral abnormalities, one or more of the three symptoms.
* b. Encephalitis syndrome: clinical manifestations of diffuse or multifocal brain damage.
* c. Clinical manifestations of involvement of the basal ganglia and/or diencephalon/hypothalamus.
* d. Mental disorder, and the psychiatric specialist believes that it does not meet the non-organic disease.
B. Auxiliary examination: one or more of the following auxiliary examination findings, or combined with related tumors.
* a. Abnormal cerebrospinal fluid: cerebrospinal fluid leukocytosis (\>5ร106/L), or cerebrospinal fluid cytology shows lymphocytic inflammation, or specific oligoclonal bands are positive.
* b. Neuroimaging or electrophysiological abnormalities: MRI limbic system T2 or FLAIR abnormal signals, unilateral or bilateral, or other areas of T2 or FLAIR abnormal signals (excluding nonspecific white matter changes and stroke); or PET imaging limbic system hypermetabolism changes, or multiple cortical and/or basal ganglia hypermetabolism. Figure 1 shows the typical neuroimaging manifestations of AE patients. Abnormal electroencephalogram, manifested as focal epilepsy or epileptiform discharge (located in the temporal lobe or outside the temporal lobe), or diffuse or multifocal slow wave rhythm. In adult patients with anti-NMDAR encephalitis, abnormal delta brush waves (extreme delta brush) often correspond to prolonged hospitalization and poor prognosis.
* c. Specific types of tumors associated with AE, such as limbic encephalitis combined with small cell lung cancer, anti-NMDAR encephalitis combined with ovarian teratoma.
C. Confirmatory experiments: positive anti-neuronal antibodies. Including NMDA-R, LGI-1, CASPR2, IgLON5, GABAA/BR, GlyR, AMPAR and axonal protein-3ฮฑ and intracellular substance antibodies anti-Hu, anti-Ma2, anti-CRMP5, anti-Yo, anti-double carrier protein, anti-GAD, etc.
D. Reasonably exclude other causes (refer to the differential diagnosis section of the consensus).
Diagnostic criteria: including possible AEs and confirmed AEs:
1. Possible AEs: meet the three diagnostic criteria of A, B and D.
2. Confirmed AEs: meet the four diagnostic criteria of A, B, C and D. 1.1.5. AE symptoms occurred โค9 months before randomization 1.1.6. Subjects meet new AEs
\- New onset: defined as subjects with NMDA-R or LGI-1 AEs and meeting the following criteria:
* The mRS score measured at baseline is stable (at least 24 hours) and is โฅ2 points.
* Received the first acute first-line treatment within 6 weeks before randomization (baseline visit).
1.1.7. All females of childbearing potential and all males must use contraception during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.
1.1.8. Stable neurological examination within 30 days before baseline (Visit 1).
1.2 Additional inclusion criteria for the NMDA-R AE cohort
In addition to the criteria outlined in Section 1.1, only subjects who met all of the following criteria were eligible for inclusion in the NMDA-R AE cohort:
* Age โฅ 18 years at the time of informed consent
* Informed consent, as appropriate based on patient age, specific site, and national criteria
* Suspected or definite NMDAR AE diagnosis as follows:
1.2.1. Suspected NMDAR encephalitis was diagnosed when all three of the following criteria were met: 1.2.1.1 Rapid onset (less than 3 months) of at least four of the following six cardinal symptoms:
* Abnormal (psychiatric) behavior or cognitive dysfunction
* Speech dysfunction (rushing speech, hypospeech, mutism)
* Seizures
* Ataxia, dyskinesia, or rigid/abnormal posture
* Decreased level of consciousness
* Autonomic dysfunction or central hypoventilation 1.2.1.2. At least one of the following laboratory results:
* Abnormal EEG (focal or diffuse slow or disorganized activity, epileptic activity, or extreme delta brushes)
* CSF with pleocytosis or oligoclonal bands 1.2.1.3. Reasonable exclusion of other etiologies and other clear encephalitis syndromes: for example, Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary angiitis of the central nervous system (CNS), Rasmussen encephalitis.
Note: If the above three groups of symptoms in criterion 1.2.1.1 are present and accompanied by systemic teratoma, suspected NMDAR encephalitis can also be diagnosed.
1.2.2 Definite NMDAR encephalitis can be diagnosed when the following three criteria are met at the same time: 1.2.2.1. The presence of one or more of the six main symptoms described in criterion 1.2.1.1 for suspected NMDAR encephalitis.
1.2.2.2. History of anti-NMDAR (GluN1) IgG antibodies detected