Trial · NCT03993262
Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
NCT03993262, Phase 2, Recruiting, Jena University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis. Trials, record NCT03993262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03993262
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
- NCT number
- NCT03993262
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Jena University Hospital
- Conditions
- Autoimmune Encephalitis
- Interventions
- Bortezomib, Placebo
- First posted
- 2019-06-20
- Last updated
- 2025-09-04
- Other registries' IDs
- eudract:2019-001423-12
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | modified Rankin-Score (mRS) | 17 weeks after first administration of the study drug | modified Rankin-Score from 0 = no symptoms to 6 = death |
| Secondary | modified Rankin-Score (mRS) | 3, 6, 9 and 13 weeks after first administration of the study drug; GCS Score also 17 weeks after first administration of the study drug | modified Rankin-Score from 0 = no symptoms to 6 = death |
| Secondary | Length of in-hospital stay / length of ICU stay | until 17 weeks after first administration of the study drug | Number of days in hospital or on ICU for each patient from first administration of the study drug until 17 weeks after first administration of the study drug |
| Secondary | Immune response | at study start and 17 weeks after first administration of the study drug | Antibody titer (in serum and liquor) and cellular immune response (FACS analysis of liquor) |
| Secondary | neurocognitive function assessed by Montreal Cognitive Assessment | at study start and 17 weeks after first administration of the study medication | total score of the Montreal Cognitive Assessment (MoCA) (0 to max. 30 points = best possible result) |
| Secondary | neurocognitive function assessed by Mini-Mental Status Test | at study start and 17 weeks after first administration of the study medication | total score of the Mini-Mental Status Test (MMST) (0 to max 30 points = best possible result) |
| Secondary | neurocognitive function assessed by Rey Auditory Verbal Learning Test | at study start and 17 weeks after first administration of the study medication | total score of the Rey Auditory Verbal Learning Test (RAVLT) (memory performance assessed by 3 word lists which are read to the patient and should be recalled and repeated by the patient; different proceeding for the 3 word lists) |
| Secondary | neurocognitive function assessed by Neuropsychiatric Inventory Questionnaire | at study start and 17 weeks after first administration of the study medication | total score of the Neuropsychiatric Inventory Questionnaire (NPI) (0 = best score to max 36 (patient) or 60 (caregiver) |
| Secondary | safety of Bortezomib regarding polyneuropathy, increase of liver enzymes and secondary infections | until 17 weeks after first administration of the study drug | number of polyneuropathy cases, number of increased liver enzymes, number of secondary infections |
| Secondary | safety of Bortezomib regarding polyneuropathy | until 17 weeks after first administration of the study drug | number of polyneuropathy cases |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32641101 | DERIVED |
Source PubMed
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Learning | Secondary outcome |
Source ConductCognition
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/NCT03993262
GET https://conductscience.org/api/trials/v1/NCT03993262/registered