Trial · NCT03993262
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| Secondary | safety of Bortezomib regarding increase of liver enzymes | until 17 weeks after first administration of the study drug | number of increased liver enzyme values |
| Secondary | Secondary infections due to Bortezomib | until 17 weeks after first administration of the study drug | number of secondary infections |
| Secondary | Hematotoxicity events due to Bortezomib | until 17 weeks after first administration of the study drug | number of hematotoxicity events |
| Secondary | Gastrointestinal toxicity due to Bortezomib | until 17 weeks after first administration of the study drug | number of gastrointestinal toxicity events |
| Secondary | total Glasgow Coma Scale (GCS) | 3, 6, 9, 13 and 17 weeks after first administration of the study drug | GCS from 3 to 15 points (sum of 3 subscores eye response (1 to 4 points), motor response (1 to 6 points), verbal response (1 to 5 points); highest score = best score; 1= worst score) |
| Secondary | Destruction marker UCH-L1 (Ubiquitin carboxy-terminal hydrolase L1) in serum and liquor | at baseline visit and 17 weeks after first administration of the study drug | Analysis of destruction marker UCH-L1 in serum and liquor |
| Secondary | Destruction marker Neurofilament light chain (in serum and liquor) | at baseline visit and 17 weeks after first administration of the study drug | Analysis of destruction marker Neurofilament light chain in serum and liquor |
| Secondary | Destruction markers GFAP (glial fibrillary acidic protein) in serum and liquor | at baseline visit and 17 weeks after first administration of the study drug | Analysis of destruction marker GFAP in serum and liquor |
| Secondary | Destruction marker TAU proteins in serum and liquor | at baseline visit and 17 weeks after first administration of the study drug | Analysis of destruction marker TAU in serum and liquor |
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.
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