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NCT02201108CompletedPhase 3

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis

A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Source: ClinicalTrials.gov · Last updated 6 Feb 2025

Brief summary (registry, in English)

Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS). Secondary Objective: * To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function. * To evaluate the safety and tolerability of teriflunomide in comparison to placebo. * To evaluate the pharmacokinetics (PK) of teriflunomide.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
166 (actual)
First submitted
17 Jul 2014
Start date
16 Jul 2014
Primary completion date
25 Oct 2019
Lead sponsor
Genzyme, a Sanofi Company
NCT number
NCT02201108
EudraCT number
2011-005249-12

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 166
  • From 16 Jul 2014 to the primary completion date, 25 Oct 2019
  • 57 sites in 22 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.

Prior treatment

  • Relapse within 30 days prior to randomization.
  • Treated with:
    • glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization.
    • fingolimod, or intravenous immunoglobulins within 3 months prior to randomization.
    • natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization.
    • cladribine or mitoxantrone within 2 years prior to randomization.
  • Treated with alemtuzumab at any time.

Other illness

  • History of human immunodeficiency virus infection.

Other

  • Expanded disability status scale score greater than 5.5 at screening or randomization visits.
  • Contraindication for MRI.
  • Pregnant or breast-feeding females or those who plan to become pregnant during the study.
  • Female participants of child-bearing potential not using highly effective contraceptive method (contraception in both female and male was required).
    • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Criteria the registry did not label

  • Participants with relapsing MS were eligible. Participants who met the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 and had:
    • at least one relapse (or attack) in the 12 months preceding screening or,
    • at least two relapses (or attack) in the 24 months preceding screening.
  • Less than 18 years of age and greater than or equal to (\>=) 10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, less than or equal to 17 years of age and \>= 13 years of age at randomization.
  • Signed informed consent/assent obtained from participant and participant's legal representative (parents or guardians) according to local regulations.

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (57)

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

SiteCityCountrySite status
Investigational Site Number : 056002
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GhentBelgiumUnknown status
Investigational Site Number : 056001
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LeuvenBelgiumUnknown status
Investigational Site Number : 100001
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SofiaBulgariaUnknown status
Investigational Site Number : 124001
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CalgaryCanadaUnknown status
Investigational Site Number : 156002
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BeijingChinaUnknown status
Investigational Site Number : 156010
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BeijingChinaUnknown status
Investigational Site Number : 156001
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BeijingChinaUnknown status
Investigational Site Number : 156006
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ChangchunChinaUnknown status
Investigational Site Number : 156007
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ChangshaChinaUnknown status
Investigational Site Number : 156008
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ChengduChinaUnknown status
Investigational Site Number : 156005
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ChongqingChinaUnknown status
Investigational Site Number : 156012
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GuangzhouChinaUnknown status
Investigational Site Number : 156004
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ShanghaiChinaUnknown status
Investigational Site Number : 156003
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ShanghaiChinaUnknown status
Investigational Site Number : 156011
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ShijiazhuangChinaUnknown status
Investigational Site Number : 156009
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TaiyuanChinaUnknown status
Investigational Site Number : 233001
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TallinnEstoniaUnknown status
Investigational Site Number : 724002
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MurciaSpainUnknown status
Investigational Site Number : 250001
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Le Kremlin-BicêtreFranceUnknown status
Investigational Site Number : 250002
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LyonFranceUnknown status
Investigational Site Number : 250003
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RennesFranceUnknown status
Investigational Site Number : 250005
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ToulouseFranceUnknown status
Investigational Site Number : 826003
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BirminghamUnited KingdomUnknown status
Investigational Site Number : 826001
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LondonUnited KingdomUnknown status
Investigational Site Number : 300002
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AthensGreeceUnknown status
Investigational Site Number : 300001
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ThessalonikiGreeceUnknown status
Investigational Site Number : 376001
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JerusalemIsraelUnknown status
Investigational Site Number : 376003
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Tel HaShomerIsraelUnknown status
Investigational Site Number : 422001
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BeirutLebanonUnknown status
Investigational Site Number : 440001
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KaunasLithuaniaUnknown status
Investigational Site Number : 504004
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FesMoroccoUnknown status
Investigational Site Number : 504005
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MarrakeshMoroccoUnknown status
Investigational Site Number : 807002
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ShtipNorth MacedoniaUnknown status
Investigational Site Number : 807001
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SkopjeNorth MacedoniaUnknown status
Investigational Site Number : 528001
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RotterdamNetherlandsUnknown status
Investigational Site Number : 620001
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CoimbraPortugalUnknown status
Investigational Site Number : 688002
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BelgradeSerbiaUnknown status
Investigational Site Number : 643001
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MoscowRussiaUnknown status
Investigational Site Number : 643003
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Nizhny NovgorodRussiaUnknown status
Investigational Site Number : 643004
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NovosibirskRussiaUnknown status
Investigational Site Number : 643005
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Saint PetersburgRussiaUnknown status
Investigational Site Number : 643002
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Saint PetersburgRussiaUnknown status
Investigational Site Number : 788001
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ManoubaTunisiaUnknown status
Investigational Site Number : 788004
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SfaxTunisiaUnknown status
Investigational Site Number : 788002
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SfaxTunisiaUnknown status
Investigational Site Number : 804001
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KharkivUkraineUnknown status
Investigational Site Number : 804002
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KharkivUkraineUnknown status
Massachusetts General Hospital Site Number : 840002
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BostonUnited StatesUnknown status
North Central Neurology Associates, PC Site Number : 840003
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CullmanUnited StatesUnknown status
Raleigh Neurology Associates Site Number : 840004
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RaleighUnited StatesUnknown status
Axiom Clinical Research of Florida Site Number : 840012
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TampaUnited StatesUnknown status
Investigational Site Number : 792001
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AnkaraTurkey (Türkiye)Unknown status
Investigational Site Number : 792002
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AnkaraTurkey (Türkiye)Unknown status
Investigational Site Number : 792003
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 792006
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 792008
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IzmirTurkey (Türkiye)Unknown status
Investigational Site Number : 792007
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IzmirTurkey (Türkiye)Unknown status

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