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Trial · NCT07583641

Registered outcomes55

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryIncidence and prevalence of antibodies against rHuPH20 in plasma over timeup to 24 weeksrHuPH20 = Recombinant Human Hyaluronidase PH20
SecondaryChange in CASE score in the NMDAR population compared with the non-NMDAR populationup to 24 weeks
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.
SecondaryChange in RBANS total scoreweek 24 to week 48
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.
SecondaryPercentage of participants with maintained change in the CASE total score (defined as stable or improving)week 24 to week 48
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.
SecondaryPercentage of participants with maintained mRS score (defined as stable or improving)week 24 to week 48
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).
SecondaryChange in NPI-C total scoreweek 24 to week 48
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. These item scores are then summed to create a total domain score.
SecondaryProportion of participants requiring rescue or second-line AIE therapiesweek 24 to week 48AIE = Auto-Immune Encephalitis
SecondaryTime to participants requiring rescue or second-line AIE therapiesweek 24 to week 48AIE = Auto-Immune Encephalitis
SecondaryChange in CASEweek 24 to week 48
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.
SecondaryChange in mRsweek 24 to week 48
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).
SecondaryChange in RBANSweek 24 to week 48
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.
SecondaryTime to resolution of status epilepticusweek 24 to week 48
SecondaryProportion of participants with seizure freedom for at least the 28 consecutive days preceding the participants in final Part of trialweek 24 to week 48mRS=modified Rankin Scale
SecondaryIncidence and prevalence of ADA against efgartigimod in serumweek 24 to week 48ADA = antidrug antibody(ies)
SecondaryPercent change in total IgG levels in serumweek 24 to week 48IgG = Immunoglobulin G

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.

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