Trial · NCT05893225
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in walking speed | From baseline to 96 weeks | Change in walking speed as measured by the Timed 25 Foot Walk (T25FW) between baseline and 96 weeks of treatment |
| Secondary | Change in cognitive function | From baseline to 96 weeks | Change in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment |
| Secondary | Change in hand function | From baseline to 96 weeks | Change in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment |
| Secondary | Change in EDSS | From 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. |
| Secondary | Change in brain volume | From baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks | Change 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 |
| Secondary | Change in T2 lesion volume | From baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks | Change in T2 lesion volume from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks |
| Secondary | Change in T1 lesion volume | From baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks | Change in T1 lesion volume from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks |
| Secondary | Change in brain magnetic resonance imaging diffusion tensor imaging (MRI-DTI) metrics | From baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks | Change in brain MRI-DTI metrics from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks |
| Other | Change in quality of life measured by EQ-5D-5L | From 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. |
| Other | Change in quality of life measured by MSIS-29 | From 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). |
| Other | Change in the Composite endpoint | From 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. |
| Other | Change in 2 minute walk test | From baseline to 96 weeks | Change in 2 minute walk test between baseline and 96 weeks of treatment |
| Other | Change in number of susceptibility weighted imaging (SWI) lesions | From baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks | Change in number of SWI lesions from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks |
| Other | Change 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. |
| Other | Health resource questionnaire | From baseline to 96 weeks | This 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05893225/registered