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NCT01285479Completed

The Gilenya Pregnancy Registry

The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 22 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
312 (actual)
First submitted
26 Jan 2011
Start date
Oct 2011
Primary completion date
May 2024
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT01285479

What you commit to

  • Study type: Observational
  • Participants enrolled: 312
  • From Oct 2011 to the primary completion date, May 2024
  • 61 sites in 34 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • There are no specific exclusion criteria for this registry.

Who the study is looking for

  • Any woman with a diagnosis of MS
  • Any woman currently pregnant
  • Exposure to fingolimod during pregnancy or up to 8 weeks before LMP
  • Signed informed consent

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Abu DhabiUnited Arab EmiratesUnknown status
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DubaiUnited Arab EmiratesUnknown status
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Bahía BlancaArgentinaUnknown status
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CórdobaArgentinaUnknown status
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GrazAustriaUnknown status
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LinzAustriaUnknown status
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Box HillAustraliaUnknown status
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BrasschaatBelgiumUnknown status
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LeuvenBelgiumUnknown status
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Rio de JaneiroBrazilUnknown status
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Saint-LaurentCanadaUnknown status
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BaselSwitzerlandUnknown status
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BernSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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Sankt GallenSwitzerlandUnknown status
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BogotaColombiaUnknown status
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NicosiaCyprusUnknown status
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Ostrava-PorubaCzechiaUnknown status
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BochumGermanyUnknown status
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AalborgDenmarkUnknown status
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AarhusDenmarkUnknown status
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CopenhagenDenmarkUnknown status
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SønderborgDenmarkUnknown status
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MadridSpainUnknown status
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SevilleSpainUnknown status
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TampereFinlandUnknown status
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TurkuFinlandUnknown status
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BronFranceUnknown status
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CahorsFranceUnknown status
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Newcastle upon TyneUnited KingdomUnknown status
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NorwichUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
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AthensGreeceUnknown status
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BudapestHungaryUnknown status
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GyőrHungaryUnknown status
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DublinIrelandUnknown status
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JerusalemIsraelUnknown status
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Ramat GanIsraelUnknown status
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CataniaItalyUnknown status
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FlorenceItalyUnknown status
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GenovaItalyUnknown status
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MilanItalyUnknown status
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OrbassanoItalyUnknown status
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RomaItalyUnknown status
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BeirutLebanonUnknown status
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Mexico CityMexicoUnknown status
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AmsterdamNetherlandsUnknown status
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LubinPolandUnknown status
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WarsawPolandUnknown status
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AmadoraPortugalUnknown status
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PortoPortugalUnknown status
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BucharestRomaniaUnknown status
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MoscowRussiaUnknown status
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JeddahSaudi ArabiaUnknown status
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RiyadhSaudi ArabiaUnknown status
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GothenburgSwedenUnknown status
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MariborSloveniaUnknown status
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BratislavaSlovakiaUnknown status
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CambridgeUnited StatesUnknown status
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Fort LauderdaleUnited StatesUnknown status
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Grand ForksUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.