Multiple Sclerosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
This trial has three groups. Please read the group that may apply to you:
Group 1 – Siponimod-Exposed Group:
- You are currently pregnant
- You have been diagnosed with Multiple Sclerosis (MS)
- You took the MS medication siponimod (Mayzent) at any point during your pregnancy or just before conception, at any dose and for any length of time
- You agree to follow the study requirements, including scheduled interviews, sharing medical records, allowing a physical examination of your baby if born alive, and completing a child development questionnaire
Group 2 – MS Comparison Group:
- You are currently pregnant
- You have been diagnosed with MS
- You may or may not be taking other MS medications during this pregnancy (but not siponimod)
- You agree to follow the study requirements, including scheduled interviews, sharing medical records, allowing a physical examination of your baby if born alive, and completing a child development questionnaire
Group 3 – Healthy Comparison Group:
- You are currently pregnant and do not have MS or any autoimmune disease
- You agree to follow the study requirements, including scheduled interviews, sharing medical records, allowing a physical examination of your baby if born alive, and completing a child development questionnaire
Who may not be able to join:
Group 1 – Siponimod-Exposed Group:
- You previously enrolled in this study during an earlier pregnancy
- You took siponimod for a reason other than an approved medical use
- You took certain other MS medications (including cladribine/Mavenclad, fingolimod/Gilenya, ozanimod, teriflunomide/Aubagio, or certain antibody-based MS drugs) within a specific window of time before conception (confirm with trial site)
- You are enrolling after your pregnancy has already ended and the outcome is already known
- A medical test done before enrolling has confirmed a major physical birth defect in your baby (note: having had a screening test with a normal or uncertain result does not automatically exclude you — confirm with trial site)
Group 2 – MS Comparison Group:
- You took siponimod at any point around the time of conception or during your pregnancy
- You took certain other MS medications (including cladribine/Mavenclad, fingolimod and other S1P modulators, teriflunomide/Aubagio, or certain antibody-based MS drugs) within a specific window of time before conception (confirm with trial site)
- You previously enrolled in this study or a related study during an earlier pregnancy
- You are enrolling after your pregnancy has already ended and the outcome is already known
- A medical test done before enrolling has confirmed a major physical birth defect in your baby (note: having had a screening test with a normal or uncertain result does not automatically exclude you — confirm with trial site)
Group 3 – Healthy Comparison Group:
- You took siponimod (Mayzent) or Kesimpta at any point around conception or during your pregnancy
- You have a diagnosis of MS or any autoimmune disease
- A medical test before enrolling confirmed a major physical birth defect in your baby (confirm with trial site)
- You previously enrolled in this study or a related study during an earlier pregnancy
- You are enrolling after your pregnancy has already ended and the outcome is already known
- You have been exposed to a substance known to cause birth defects during your pregnancy, as confirmed by the study research center
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Phone: 1-888-669-6682
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Prevalence of major structural defects
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.