Trial · NCT05177939
Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis
NCT05177939, Phase 3, Unknown, Nihon Pharmaceutical Co., Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis. Trials, record NCT05177939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05177939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis
- NCT number
- NCT05177939
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Conditions
- Autoimmune Encephalitis
- Interventions
- NPB-01, NPB-01-ME
- First posted
- 2022-01-05
- Last updated
- 2022-12-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05177939
GET https://conductscience.org/api/trials/v1/NCT05177939/registered