Trial · NCT05177939
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis) | 4 weeks | 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. |
| Secondary | CASE | 1, 2, 3, 4, 6, 8, 12 weeks | 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. |
| Secondary | mRS | 1, 2, 3, 4, 6, 8, 12 weeks | 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. |
| Secondary | GCS | 1, 2, 3, 4, 6, 8, 12 weeks | 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. |
| Secondary | MMSE-J | 4, 8, 12 weeks | 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. |
| Secondary | FAB | 4, 8, 12 weeks | 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. |
| Secondary | Disappearance of abnormal EEG findings | 4, 12 weeks | 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. |
| Secondary | Disappearance of abnormal head MRI findings | 4, 12 weeks | 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. |
| Secondary | Cerebrospinal fluid test | 4, 12 weeks | 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. |
| Secondary | Duration of hospitalization | 12 weeks | Duration of hospitalization after the start of treatment with investigational product to be compared between the arms. |
| Secondary | mRS proportion | 1, 2, 3, 4, 6, 8, 12 weeks | 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) . |
| Secondary | GCS proportion | 1, 2, 3, 4, 6, 8, 12 weeks | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05177939/registered