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Trial · NCT06118398

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryChange in Expanded Disability Status Scale (EDSS) score from baseline.1 monthChange in Expanded Disability Status Scale (EDSS) score from baseline to 1 month after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
SecondaryChange in Expanded Disability Status Scale (EDSS) score from baseline.3 months, 6 monthsChange in Expanded Disability Status Scale (EDSS) score from baseline to 3 months, 6 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
SecondaryPercentage of Participants with Disability Improvement1 month, 3 months, 6 months
Disability improvement is defined as a reduction in EDSS score of: A) ≥1.0 point from the baseline EDSS score when the baseline score was ≤5.5; B) ≥0.5 point when the baseline EDSS score \> 5.5(EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
SecondaryChange in modified Rankin score (mRS) from baseline.1 month, 3 months, 6 monthsChange in modified Rankin score (mRS) from baseline at 1 month 1, 3 month 3 and 6 month (mRS: Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
SecondaryTime to first relapse6 months
SecondaryNumber of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)6 monthsNumber of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) at the last visit.
SecondaryChange in timed 25 Foot Walk Test from baseline.1 month, 3 months, 6 monthsChange in time taken to complete the timed 25 Foot Walk Test from baseline.
SecondaryNumber of NMOSD attacked during follow-up6 monthsNumber of NMOSD treatment related to acute attack during follow-up.
SecondaryChange in serum GFAP levels from baseline1 month, 6 monthsChange in serum GFAP levels from baseline to the last visit.
SecondaryChange in AQP4-ab titres from baseline1month, 6 monthsChange in AQP4-ab titres from baseline to the last visit
SecondaryChange in serum NfL levels from baseline1 month, 6 monthsChange in serum NfL levels from baseline to the last visit
SecondaryChange in Visual Acuity (VA) from baseline1 month, 6 monthsChange in Visual Acuity (VA) at1 month 1, and 6 month.
SecondaryChanges in EQ-5D-5L scores from baseline6 monthsChanges in EQ-5D scores from baseline to month 6(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
SecondaryChange in retinal nerve fibre layer (RNFL) loss from baseline1 month,6 monthsChange in retinal nerve fibre layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 1, month 6.
SecondaryAdverse reactions during treatment and follow-up6 months

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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