A Multicenter Longitudinal Open-Label Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Relapsing Multiple Sclerosis
  • Age: Between 18 years - 65 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must provide written informed consent
    2. Willing and able to adhere to the study visit schedule and other protocol requirements
    3. Has a diagnosis of multiple sclerosis (MS)
    4. Has = 5 years since time of relapsing multiple sclerosis (RMS) diagnosis
    5. Has been treated with = 1 approved RMS DMT at time of study enrollment
    6. Has no history of relapse with onset from 30 days
    7. Participants must have documentation of positive varicella zoster virus (VZV)immunoglobulin G (IgG) antibody status or complete VZV vaccination
    8. Females of childbearing potential (FCBP) must agree to practice a highly effective method of contraception

You may not be eligible for this study if the following are true:

    1. Has as any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
    2. Has a presence of other neurologic disorders to explain the progressive neurologic disability or that might affect cognition
    3. Has a visual or other sensorimotor impairment likely to confound test performance
    4. Has a presence of > 10 GdE lesions on the Baseline brain MRI scan
    5. Has a history of developmental disorder
    6. Has a motor or sensory defect that might interfere with cognitive test performance
    7. Has contraindications to MRI or gadolinium contrast
    8. Pregnant, lactating, or has a positive serum beta human chorionic gonadotropin (ß-hCG) measured
    9. Has any condition that would make implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
    10. Has a history of uveitis or macular edema
    11. Has a known active bacterial, viral, fungal, mycobacterial infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of S
    12. Has a history or known presence of recurrent or chronic infection (eg, hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]
    13. Testing positive for acute or chronic hepatitis A, B, or C,
    14. History of cancer within 5 years
    15. Has attempted suicide 365 days prior
    16. Hypersensitivity to active ingredients or excipients of ozanimod
    17. Prior participation in an ozanimod clinical study
    18. History of treatment with an MS investigational agent prior to the first dose of IP



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