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Trial · NCT05319093

Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients

NCT05319093, Terminated, Brigham and Women's Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients. Trials, record NCT05319093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05319093

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients
NCT number
NCT05319093
Status
Terminated
Enrollment
26 participants, actual
Lead sponsor
Brigham and Women's Hospital
Conditions
Fatigue, Multiple Sclerosis
Interventions
Ozanimod
First posted
2022-04-08
Last updated
2025-11-28

Source ClinicalTrials.gov

Registered outcomes9

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

ListOutcomeTime frameDescription
PrimaryThree-months change in Modified Fatigue Impact Scale (MFIS) score3 months
Difference in Modified Fatigue Impact Scale (MFIS) score between baseline (treatment initiation) and month 3. MFIS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.
SecondaryThree-months change in Chalder Fatigue Scale (CFS) score3 months
Difference in Chalder Fatigue Scale (CFS) score between baseline (treatment initiation) and month 3. CFS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.
SecondaryThree-months change in Fatigue Severity Scale (FSS) score3 months
Difference in Fatigue Severity Scale (FSS) score between baseline (treatment initiation) and month 3. FSS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.
SecondaryThree-months change in NeuroQOL-fatigue questionnaire score3 months
Difference in NeuroQOL-fatigue scale score between baseline (treatment initiation) and month 3. NeuroQOL-fatigue score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.
SecondaryVisual Analog Scale (VAS) for fatigue score3 monthsChange in VAS fatigue score over the observation period. Current fatigue level will be assessed using VAS every four hours while the patient is awake during the trial period.
SecondaryThree-months change in NeuroQOL-cognitive function questionnaire score3 months
Difference in NeuroQOL-cognitive function scale score between baseline (treatment initiation) and month 3. Cognitive function will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.
OtherNeuroQOL-depression scale3 monthsLevel of depression will be assessed using the NeuroQOL-depression scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.
OtherNeuroQOL-anxiety scale3 monthsLevel of anxiety will be assessed using the NeuroQOL-anxiety scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.
OtherEpworth Sleepiness scale3 monthsSleep abnormalities will be assessed using the Epworth Sleepiness scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.

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.

Papers17

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
1798888BACKGROUNDPubMed
2803071BACKGROUNDPubMed
4053261BACKGROUNDPubMed
17409388BACKGROUNDPubMed
20630259BACKGROUNDPubMed
22573626BACKGROUNDPubMed
22935407BACKGROUNDPubMed
26920374BACKGROUNDPubMed
28548605BACKGROUNDPubMed
28870581BACKGROUNDPubMed

1 to 10 of 17

See all 17 papers

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT05319093

GET https://conductscience.org/api/trials/v1/NCT05319093/registered