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Trial · NCT05893225

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryChange in walking speedFrom baseline to 96 weeksChange in walking speed as measured by the Timed 25 Foot Walk (T25FW) between baseline and 96 weeks of treatment
SecondaryChange in cognitive functionFrom baseline to 96 weeksChange in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment
SecondaryChange in hand functionFrom baseline to 96 weeksChange in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment
SecondaryChange in EDSSFrom baseline to 96 weeks
Change in Expanded Disability Status Scale. The EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10.0 (death) and is determined based on functional system scores (FSS) that are assigned after a standardized clinical neurological examination.
SecondaryChange in brain volumeFrom baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeksChange in brain volume (whole brain volume and gray matter volume) from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
SecondaryChange in T2 lesion volumeFrom baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeksChange in T2 lesion volume from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
SecondaryChange in T1 lesion volumeFrom baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeksChange in T1 lesion volume from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
SecondaryChange in brain magnetic resonance imaging diffusion tensor imaging (MRI-DTI) metricsFrom baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeksChange in brain MRI-DTI metrics from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
OtherChange in quality of life measured by EQ-5D-5LFrom baseline to 96 weeks
Change in quality of life as measured by EuroQol 5-dimension, 5-level (EQ-5D-5L) questionnaire between baseline and 96 weeks of treatment. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
OtherChange in quality of life measured by MSIS-29From baseline to 96 weeks
Change in quality of life as measured by Multiple Sclerosis Impact Scale-29 between baseline and 96 weeks of treatment. The MSIS, is a 29-item patient-reported measure of the physical and psychological impacts of MS. Patients are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
OtherChange in the Composite endpointFrom baseline to 96 weeks
Change in the Composite endpoint as measured by Overall Disability Response Score (ODRS) between baseline and 96 weeks of treatment. The ODRS is based on changes in EDSS, T25FW and 9HPT. At each time point, in individual patients, the scores of the four components are summed, which leads to a total score ranging from +4 to -4. A positive ODRS score means that there is a disability improvement compared to baseline and a negative ODRS score means a disability worsening from baseline.
OtherChange in 2 minute walk testFrom baseline to 96 weeksChange in 2 minute walk test between baseline and 96 weeks of treatment
OtherChange in number of susceptibility weighted imaging (SWI) lesionsFrom baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeksChange in number of SWI lesions from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
OtherChange in caregiver strain index (CSI)From baseline to 96 weeks
Change in caregiver strain index from baseline to 96 weeks. It is a 13-question tool that measures strain related to care provision. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time.
OtherHealth resource questionnaireFrom baseline to 96 weeksThis questionnaire is adapted from Kobelt et al. and will be used to generate data for health economic analysis.

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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