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Completed No phase listed Observational

The Gilenya Pregnancy Registry

ClinicalTrials.gov ID: NCT01285479

Public ClinicalTrials.gov record NCT01285479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 9:22 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.

Study identification

NCT ID
NCT01285479
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
312 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 15, 2011 (Actual)
Primary completion
May 29, 2024 (Actual)
Completion
May 29, 2024 (Actual)
Last update posted
Jan 22, 2025

2011 – 2024

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Novartis Investigative Site Fort Lauderdale Florida 33308 —
Novartis Investigative Site Cambridge Massachusetts 02139 —
Novartis Investigative Site Grand Forks North Dakota 58201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01285479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 22, 2025 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01285479 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →