Autoimmune Encephalitis Clinical Trial
Official title:
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy
To compare the efficacy and safety of NPB-01 in patients with autoimmune encephalitis refractory to steroid pulse therapy using steroid pulse therapy as a control.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria - < At 1st registration > Patients meeting the possible diagnostic criteria for autoimmune encephalitis - < At 1st registration > Patients with a CASE score of 5 to 22 during the screening period - < At 1st registration > Patients with autoimmune encephalitis in progress (active and requiring therapeutic intervention) - < At 1st registration > IVIG therapy and steroid pulse therapy are considered necessary by the investigator. - < At 1st registration > Patients aged 15 years or older at the time of informed consent - < At 2nd registration > Patients who meet any of the following (1) to (6): 1. Definite diagnostic criteria for autoimmune limbic encephalitis 2. MRI evidence of demyelination (probable autoimmune encephalitis) 3. Probabilistic diagnostic criteria for anti-NMDAR encephalitis 4. Probabilistic diagnostic criteria for Bickerstaff brainstem encephalitis 5. Probabilistic diagnostic criteria for Hashimoto's encephalopathy 6. Diagnostic Criteria for Autoimmune Encephalitis with Negative but Probable Autoantibodies - < At 2nd registration > CASE score of 5 to 22 on Day 8 of the previous treatment period - < At 2nd registration > Patients who have had an inadequate response to steroid pulse therapy Exclusion Criteria: - < At 1st registration > Patients with strongly suspected infectious encephalitis - < At 1st registration > Patients who received immunoglobulin preparations within 8 weeks prior to informed consent - < At 1st registration > Patients who received plasma exchange within 4 weeks prior to informed consent - < At 1st registration > Patients who received immunosuppressants (Rituximab, cyclophosphamide, etc.) within 4 weeks prior to informed consent - < At 1st registration > Patients who have had tumor resection associated with autoimmune encephalitis within 4 weeks prior to informed consent - < At 1st registration > Patients with a history of shock or hypersensitivity to the ingredients of NPB-01 - < At 1st registration > Patients with known IgA deficiency - < At 1st registration > Patients with renal disorder - < At 1st registration > Patients with a current or previous history of cerebral or cardiovascular disorders (Asymptomatic cerebral infarction and myocardial infarction that occurred more than 5 years ago are not applicable.) - < At 1st registration > Patients at high risk of thromboembolism - < At 1st registration > Patients with haemolytic/blood loss anaemia - < At 1st registration > Immunosuppressed/immunocompromised patients - < At 1st registration > Patients with decreased cardiac function - < At 1st registration > Pregnant, expected (desired or planned) pregnant, or breastfeeding patients - < At 1st registration > Use of prohibited medications or treatment in this study - < At 1st registration > Patients who received investigational product in this study (re-enrollment prohibited) - < At 1st registration > Patients who have received treatment with investigational product other than this study within 4 months prior to informed consent - < At 1st registration > Patients with a history of hypersensitivity to methylprednisolone sodium succinate - < At 1st registration > Patients who have a tumor associated with autoimmune encephalitis and are considered to require resection during the study period. - < At 1st registration > Patients receiving intravenous general anesthetics or sedative hypnotics - < At 1st registration > Patients in coma - < At 1st registration > Ventilated patients - < At 1st registration > Patients who cannot undergo protocol-specified tests/assessments - < At 1st registration > Other patients considered ineligible for the study by the investigator - < At 2nd registration > Positive herpes simplex virus DNA qualitative test in the screening period. - < At 2nd registration > Serum creatinine = 2 times the upper limit of normal during the screening period. - < At 2nd registration > Total protein = 9 g/dL during the screening period. - < At 2nd registration > Patients with hematocrit = 55% during the screening period - < At 2nd registration > Patients who meet any of the exclusion criteria at the time of first registration |
Country | Name | City | State |
---|---|---|---|
Japan | Trial site 1 | Ube | Yamaguchi |
Lead Sponsor | Collaborator |
---|---|
Nihon Pharmaceutical Co., Ltd |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis) | A responder is defined as a patient whose CASE score at Week 4 of the post-treatment follow-up period after treatment with investigational product improved by 40% or more compared to the pre-treatment period. | 4 weeks | |
Secondary | CASE | The change in CASE score at each time point after the start of treatment with investigational product compared with that on Day 8 of the pretreatment period will be compared between the arms. Changes in CASE scores divided into three segments (0 -4: excellent, 5 -9: moderate, 10 -27: poor) will also be compared.
In addition, the period until CASE score becomes 4 points or less after the start of treatment with investigational product will be checked. |
1, 2, 3, 4, 6, 8, 12 weeks | |
Secondary | mRS | Changes in mRS at each time point after the start of investigational product treatment compared with Day 8 of the pretreatment period will be compared between the arms. | 1, 2, 3, 4, 6, 8, 12 weeks | |
Secondary | GCS | To compare the change in GCS at each time point after the start of investigational product with that on Day 8 of the pretreatment period between the arms. | 1, 2, 3, 4, 6, 8, 12 weeks | |
Secondary | MMSE-J | The change in MMSE-J at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 8, 12 weeks | |
Secondary | FAB | The change in FAB at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 8, 12 weeks | |
Secondary | Disappearance of abnormal EEG findings | The proportion of subjects in whom abnormal findings in EEG disappeared at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 12 weeks | |
Secondary | Disappearance of abnormal head MRI findings | The proportion of subjects in whom abnormal findings in head MRI disappeared at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 12 weeks | |
Secondary | Cerebrospinal fluid test | The proportion of subjects in whom the cell count returned to within the reference range (= 5/µl) and the proportion of subjects in whom the protein count returned to within the reference range (15.0 ~ 45.0 mg/dL) at each time point after the start of investigational product treatment as compared with Day 8 of the pretreatment period will be checked. | 4, 12 weeks | |
Secondary | Duration of hospitalization | Duration of hospitalization after the start of treatment with investigational product to be compared between the arms. | 12 weeks | |
Secondary | mRS proportion | The proportions of subjects with an mRS score of = 2, subjects with an improvement of = 1 point, and subjects with an improvement of = 2 points will also be compared.
Also, the time to mRS improvement after the start of treatment with investigational product (= 2 points, = 1 point improvement, = 2 points improvement) . |
1, 2, 3, 4, 6, 8, 12 weeks | |
Secondary | GCS proportion | Changes in GCS when divided into three segments (15-13: Mild, 12-9: Moderate, 8-3: Severe) will also be compared.
In addition, the period until the GCS score reaches 13 or higher after the start of treatment with investigational product will be checked. |
1, 2, 3, 4, 6, 8, 12 weeks |
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