Clinical Trial Details

NCT ID: NCT02201108
Date Last Changed: September 13, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Teriflunomide HMR1726 and Placebo for the treatment of Multiple Sclerosis

Research Study Title

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

Purpose

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.

Secondary Objectives:

  • To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.

  • To evaluate the safety and tolerability of teriflunomide in comparison to placebo.

  • To evaluate the pharmacokinetics (PK) of teriflunomide.

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Recruitment Details

Phase
3
Gender
All
Age
10 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Genzyme, a Sanofi Company
Duration
65 Months
Facility Type
N/A
Compensation

Eligibility

All ages 10 Years to 17 Years

Inclusion criteria:

  • Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:

  • at least one relapse (or attack) in the 12 months preceding randomization or

  • at least two relapses (or attack) in the 24 months preceding randomization.

  • ≤17 years of age and ≥10 years of age at randomization.

  • Signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.

Exclusion criteria:

  • EDSS score > 5.5 at screening or randomization visits.

  • 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.

  • History of HIV infection.

  • Contraindication for MRI.

  • Pregnant or breast-feeding females or those who plan to become pregnant during the study.

  • Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Site Locations (63)

Country State City Zip Facility and Contact
United States Alabama Cullman 35058 Investigational Site Number 840003
United States Georgia Savannah 31406 Investigational Site Number 840006
United States Massachusetts Boston 02114 Investigational Site Number 840002
United States North Carolina Raleigh 27607 Investigational Site Number 840004
United States Virginia Charlottesville 22903 Investigational Site Number 840005
Australia Parkville/Melbourne 3052 Investigational Site Number 036001
Belgium Gent 9000 Investigational Site Number 056002
Belgium Leuven 3000 Investigational Site Number 056001
Bulgaria Sofia 1113 Investigational Site Number 100001
Canada Calgary T3B 6A8 Investigational Site Number 124001
Canada Ottawa K1H 8L1 Investigational Site Number 124002
China Beijing 100034 Investigational Site Number 156001
China Beijing 100045 Investigational Site Number 156002
China Beijing 100730 Investigational Site Number 156010
China Changchun 130021 Investigational Site Number 156006
China Changsha 410011 Investigational Site Number 156007
China Chengdu 610041 Investigational Site Number 156008
China Chongqing 400014 Investigational Site Number 156005
China Guangzhou 510630 Investigational Site Number 156012
China Shanghai 200092 Investigational Site Number 156003
China Shanghai 201102 Investigational Site Number 156004
China Shijiazhuang 050000 Investigational Site Number 156011
China Taiyuan 030001 Investigational Site Number 156009
Estonia Tallinn 10617 Investigational Site Number 233001
France Le Kremlin Bicetre 94270 Investigational Site Number 250001
France Lyon Cedex 03 69394 Investigational Site Number 250002
France Marseille 13385 Investigational Site Number 250004
France Rennes Cedex 35033 Investigational Site Number 250003
France Toulouse 31059 Investigational Site Number 250005
Greece Thessaloniki 54642 Investigational Site Number 300001
Israel Jerusalem 91120 Investigational Site Number 376001
Israel Tel Hashomer 52621 Investigational Site Number 376003
Lebanon Beirut Investigational Site Number 422001
Lithuania Kaunas LT-50009 Investigational Site Number 440001
Netherlands Rotterdam 3015 CN Investigational Site Number 528001
Portugal Coimbra 3000-075 Investigational Site Number 620001
Russian Federation Moscow 127566 Investigational Site Number 643001
Russian Federation Nizhny Novgorod 603155 Investigational Site Number 643003
Russian Federation Novosibirsk 630087 Investigational Site Number 643004
Russian Federation Saint-Petersburg 197022 Investigational Site Number 643005
Russian Federation St-Petersburg 197110 Investigational Site Number 643002
Serbia Belgrade 11000 Investigational Site Number 688002
Spain Madrid 28040 Investigational Site Number 724003
Spain Murcia 30120 Investigational Site Number 724002
Spain Sevilla 41071 Investigational Site Number 724001
Spain Valencia 46026 Investigational Site Number 724004
Tunisia Manouba 2010 Investigational Site Number 788001
Tunisia Sfax 3029 Investigational Site Number 788002
Tunisia Sfax 3051 Investigational Site Number 788004
Turkey Ankara 06100 Investigational Site Number 792002
Turkey Ankara 06500 Investigational Site Number 792001
Turkey Istanbul 34390 Investigational Site Number 792006
Turkey Istanbul 34400 Investigational Site Number 792004
Turkey Istanbul 34688 Investigational Site Number 792003
Turkey Izmir 35210 Investigational Site Number 792008
Turkey İzmir Investigational Site Number 792007
Turkey Trabzon 61080 Investigational Site Number 792005
Ukraine Dnipro 49027 Investigational Site Number 804003
Ukraine Kharkov 61068 Investigational Site Number 804001
Ukraine Kharkov 61068 Investigational Site Number 804002
United Kingdom Birmingham B4 6NH Investigational Site Number 826003
United Kingdom London SE1 7EH Investigational Site Number 826001
United Kingdom London WC1N 3JH Investigational Site Number 826002

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