Status:
TERMINATED
Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Fatigue
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Multi-center observational study to assess the short-term response of multiple sclerosis (MS) patients initiated on Ozanimod with respect to fatigue. Patterns of brain changes on brain magnetic resona...
Detailed Description
Primary objectives: 1. To assess the effect of Ozanimod treatment on the impact of fatigue on physical, cognitive, and psychosocial functions, as measured by the modified fatigue impact scale (MFIS)....
Eligibility Criteria
Inclusion
- age≥18
- diagnosis of MS (according to the 2010 McDonald criteria)
Exclusion
- neurodegenerative disorders other than MS
- terminal medical condition
- currently treated for active malignancy
- alcohol or substance abuse in the past year, except marijuana
- non-English speakers (the mobile application is not available in other languages)
- inability to undergo MRI scan
- Patients undergoing COVID-19 vaccination will be allowed to participate in the study if at least 2 weeks have elapsed from their last dose of vaccine.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05319093
Start Date
April 1 2022
End Date
July 23 2024
Last Update
November 28 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115