Trial · NCT06334094
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
NCT06334094, Phase 4, Withdrawn, The University of Texas at Dallas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS. Trials, record NCT06334094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06334094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
- NCT number
- NCT06334094
- Status
- Withdrawn
- Phases
- Phase 4
- Enrollment
- 0 participants, actual
- Lead sponsor
- The University of Texas at Dallas
- Conditions
- Multiple Sclerosis
- Interventions
- Ozanimod
- First posted
- 2024-03-27
- Last updated
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance | 1 year | SDMT is a neuropsychological assessment of processing speed in MS. The SDMT consists of 9 symbols that correspond to a number. Participants have 90 seconds to complete as many symbol to number associations as they can. Scoring is based on how many they can complete correctly in the span of 90 seconds. Therefore, to assess MS patients' cognitive changes while on ozanimod, MS patients' baseline performance to their performance following treatment on processing speed will be compared. The primary endpoint for this study will be a change from baseline in written SDMT performance of at least 4 points. |
| Secondary | Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) | 1 year | To assess the mechanisms by which ozanimod changes processing speed in MS, fMRI measures will be obtained, including the patients' volumetric BOLD signal. To assess metrics of MS patients' structural and functional changes while on ozanimod, MS patients' resting BOLD will be measured. In the context of the within-subjects design, comparisons will be performed between each of the MS patients to themselves by comparing their baseline and treatment-assessment MR metrics. Each MS patients' resting BOLD signal will be measured at baseline, during treatment, and after ozanimod treatment. Additionally, BOLD signal of ozanimod-responders to non-responders will be compared. |
| Secondary | Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) | 1 year | To assess metrics of MS patients' neurophysiology changes while on ozanimod compared to baseline, MS patients' CBF during the treatment phase will be assessed for comparison to baseline. In the context of the within-subjects design, comparisons will be performed between each of the MS patients to themselves by comparing their baseline and treatment-assessment MR metrics. |
| Secondary | Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) | 1 year | To assess metrics of MS patients' neurophysiology changes while on ozanimod compared to baseline, MS patients' CMRO2 and CBF/CMRO2 ratio (i.e., NVC) will be assessed during the treatment phase for comparison to baseline. In the context of the within-subjects design, comparisons will be performed between each of the MS patients to themselves by comparing their baseline and treatment-assessment MR metrics. |
| Secondary | Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging | 1 year | To assess metrics of MS patients' structural and functional changes while on ozanimod, the investigators will measure MS patients' brain volume. In the context of the within-subjects design, comparisons will be performed between each of the MS patients to themselves by comparing their baseline and treatment-assessment MR metrics. |
| Secondary | Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI) | 1 year | To assess metrics of MS patients' neurophysiology changes while on ozanimod compared to baseline, MS patients' diffusion parameters of ozanimod-responders to non-responders will be assessed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06334094
GET https://conductscience.org/api/trials/v1/NCT06334094/registered