Multiple Sclerosis (MS) is an immune-mediated disease of the central nervous system (CNS) characterized by inflammation, demyelination and axonal/neuronal destruction, ultimately leading to severe disability. The primary objective of this study is to evaluate overall safety and tolerability of converting to siponimod from oral or injectable relapsing MS treatments in patients with advancing disease. We hope to provide insight into the Multiple Sclerosis disease state, as well as current treatments for managing MS symptoms.
This is a 6-month VIRTUAL trial consisting of two parts: The Screening Period and Core Treatment Period, plus a 30-day follow-up telephone call.
Patients eligible for inclusion in this study must meet the following criteria:
- 18 to 65 years (inclusive) at screening
- Patients with advancing RMS as defined by the principal investigator
- Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013)
- Disability status at screening with an EDSS score of >2.0 to 6.5 (inclusive)
- Having been continuously treated with beta-interferons, glatiramer acetate, fingolimod, dimethyl fumarate, or teriflunomide for at least 3 months at the time of consent
- Patients desiring to start treatment with a DMT investigated in advancing stages of MS
This protocol is NOT appropriate for those:
- with any active chronic disease other than MS
- who are pregnant, breast feeding, or may become pregnant
- with a history of malignancy, diabetes mellitus, macular edema in the past year, hepatitis, or any active systemic viral, bacterial, or fungal infection
- with conditions or undergoing treatments which affect cardiovascular function
- history of substance abuse (drug or alcohol) or any other factor (i.e. serious psychiatric condition) that may interfere with the patient’s ability to cooperate and comply
- using other investigational drugs within 30 days or five elimination half-lives, or until the expected pharmacodynamics effect has returned to baseline, whichever is longer.
- who refuse genetic testing for CYP2C9*3
- without access to the internet and compatible electronic devices for virtual appointments
Enrollment for this trial is currently ongoing.