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  • Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.

Principal Investigator

Silvia Delgado

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20190358
National Clinical Trials Identifier NCT03623243

Clinical Trial Summary

To assess safety and tolerability of patients converting from approved Relapsing Multiple
Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.


Phase

Phase 3


Funding Agency/Sponsor

Industry


Disease

Multiple Sclerosis


Enrollment Eligibility

Key Inclusion Criteria:
1. Signed informed consent.
2. Male or female aged 18 to 65 years (inclusive).
3. Patients with advancing RMS as defined by the principal investigator.
4. Prior history of relapsing MS (RMS), with or without progressive features, according
to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
5. EDSS score of >/= 2.0 to 6.5 (inclusive).
6. Having been continuously treated with RMS Disease Modifying Therapies.
Key Exclusion criteria:
1. Pregnant or nursing (lactating) women.
2. Patients with any medically unstable condition as determined by the investigator.
3. Certain cardiac risk factors defined in the protocol
4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply.


Contact Information

Study Contact Cesar Rodriguez Suero
Phone Number +1 (305) 2433100
Email cxr910@miami.edu
Get detailed information on ClinicalTrials.Gov

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