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
- Diseases
- Multiple sclerosis
- 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
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number : 056002 Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Investigational Site Number : 056001 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Investigational Site Number : 100001 Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Investigational Site Number : 124001 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Investigational Site Number : 156002 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 156010 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 156001 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 156006 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Investigational Site Number : 156007 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Investigational Site Number : 156008 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Investigational Site Number : 156005 Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Investigational Site Number : 156012 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Investigational Site Number : 156004 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Investigational Site Number : 156003 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Investigational Site Number : 156011 Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Investigational Site Number : 156009 Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Investigational Site Number : 233001 Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Investigational Site Number : 724002 Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Investigational Site Number : 250001 Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Investigational Site Number : 250002 Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Investigational Site Number : 250003 Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Investigational Site Number : 250005 Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Investigational Site Number : 826003 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Investigational Site Number : 826001 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Investigational Site Number : 300002 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Investigational Site Number : 300001 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Investigational Site Number : 376001 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Investigational Site Number : 376003 Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
| Investigational Site Number : 422001 Coordinator of this site? Confirm its status | Beirut | Lebanon | Unknown status |
| Investigational Site Number : 440001 Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
| Investigational Site Number : 504004 Coordinator of this site? Confirm its status | Fes | Morocco | Unknown status |
| Investigational Site Number : 504005 Coordinator of this site? Confirm its status | Marrakesh | Morocco | Unknown status |
| Investigational Site Number : 807002 Coordinator of this site? Confirm its status | Shtip | North Macedonia | Unknown status |
| Investigational Site Number : 807001 Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| Investigational Site Number : 528001 Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Investigational Site Number : 620001 Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Investigational Site Number : 688002 Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Investigational Site Number : 643001 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Investigational Site Number : 643003 Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Investigational Site Number : 643004 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Investigational Site Number : 643005 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Investigational Site Number : 643002 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Investigational Site Number : 788001 Coordinator of this site? Confirm its status | Manouba | Tunisia | Unknown status |
| Investigational Site Number : 788004 Coordinator of this site? Confirm its status | Sfax | Tunisia | Unknown status |
| Investigational Site Number : 788002 Coordinator of this site? Confirm its status | Sfax | Tunisia | Unknown status |
| Investigational Site Number : 804001 Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Investigational Site Number : 804002 Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Massachusetts General Hospital Site Number : 840002 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| North Central Neurology Associates, PC Site Number : 840003 Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| Raleigh Neurology Associates Site Number : 840004 Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Axiom Clinical Research of Florida Site Number : 840012 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Investigational Site Number : 792001 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 792002 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 792003 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 792006 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 792008 Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 792007 Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.