Trial · NCT07583641
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change in RBANS in the non-NMDAR population | up to week 24 | RBANS= Repeatable Battery for the Assessment of Neuropsychological Status; NMDAR=N-methyl-D-aspartate receptor. The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is a performance outcome measure developed to identify and characterize cognitive impairment by assessing an individual's current level of cognitive performance. |
| Secondary | Change in NPI-C total score in the non-NMDAR population | up to week 24 | NPI-C= Neuropsychiatric Inventory-Clinician; NMDAR=N-methyl-D-aspartate receptor. The NPI-C Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms. Total score is calculated by summing the scores of all the individual domains. Each domain score is determined by summing the item scores within that domain. The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item. |
| Secondary | Change in mRS in the non-NMDAR population | up to week 24 | mRS= modified Rankin Scale; NMDAR=N-methyl-D-aspartate receptor. The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.Scores range from 0 (no symptoms) to 6 (dead). |
| Secondary | Percentage of CASE responders in the non-NMDAR population. | at week 24 | CASE = Clinical Assessment Scale in AIE ; NMDAR=N-methyl-D-aspartate receptor. The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness. This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability. |
| Secondary | Incidence and severity of AEs | week 24 onwards | AEs = Adverse Effects |
| Secondary | Incidence and severity of SAEs | week 24 onwards | SAEs = Serious Adverse Effects |
| Secondary | Proportion of participants with presence of neuropsychiatric symptoms, defined by NPI-C total score of at least 1 point | at week 24 | NPI-C= Neuropsychiatric Inventory-Clinician. The NPI-C (Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms. Total score is calculated by summing the scores of all the individual domains. Each domain score is determined by summing the item scores within that domain. The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item. |
| Secondary | Change in MoCA total score | up to week 24 | MoCA= Montreal Cognitive Assessment |
| Secondary | Proportion of participants with a favorable outcome in mRS where favorable outcome is defined as no worsening for participants with a baseline mRS score of ≤2 or improvement of ≥1 point for participants with a baseline mRS score of >2 | up to week 24 | mRS=modified Rankin Scale. The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities. Scores range from 0 (no symptoms) to 6 (dead). |
| Secondary | Change in CGI-S | up to week 24 | CGI-S= Clinical Global Impression of Severity. CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C. |
| Secondary | Change in CGI-C | up to week 24 | CGI-C= Clinical Global Impression of Change. CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C. |
| Secondary | Change in PGI-C | week 0 to week 24 | PGI-C =Patient Global Expression of Change. PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively. |
| Secondary | Change in PGI-S | week 0 to week 24 | PGI-S= Patient Global Expression of Severity. PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively. |
| Secondary | Time to resolution of status epilepticus | up to 24 weeks | |
| Secondary | Time to first occurrence of seizure freedom. | up to 24 weeks | Seizure freedom is defined as no seizures for at least 28 consecutive days |
| Secondary | Proportion of participants with seizure freedom for at least the 28 consecutive days | up to 24 weeks | |
| Secondary | Time to use of rescue therapy after randomization | up to 24 weeks | |
| Secondary | Trough efgartigimod serum concentrations over time | up to 24 weeks | |
| Secondary | Percent change in total IgG levels in serum | up to 24 weeks | IgG = Immunoglobulin G |
| Secondary | Incidence and prevalence of ADA against efgartigimod in serum over time | up to 24 weeks | ADA = anti drug antibodies |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07583641/registered?page=2