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Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent

NCT04933552 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 867

Last updated 2024-05-16

No results posted yet for this study

Summary

This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.

Conditions

Interventions

OTHER

Siponimod

Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2032-05-31
Completion
2032-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933552 on ClinicalTrials.gov