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

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02201108

Run by

Genzyme, a Sanofi Company

People needed

166

Starts

2014-07-16

Expected to finish

2024-07-29

Last updated by the study team

2025-02-06

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Expanded disability status scale score greater than 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 human immunodeficiency virus infection.
• 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.

Where it is running

• Axiom Clinical Research of Florida Site Number : 840012 — Tampa, Florida, United States
• Massachusetts General Hospital Site Number : 840002 — Boston, Massachusetts, United States
• Raleigh Neurology Associates Site Number : 840004 — Raleigh, North Carolina, United States
• Investigational Site Number : 056002 — Ghent, Belgium
• Investigational Site Number : 056001 — Leuven, Belgium
• Investigational Site Number : 100001 — Sofia, Bulgaria
• Investigational Site Number : 124001 — Calgary, Alberta, Canada
• Investigational Site Number : 156001 — Beijing, China
• Investigational Site Number : 156002 — Beijing, China
• Investigational Site Number : 156010 — Beijing, China
• Investigational Site Number : 156006 — Changchun, China
• Investigational Site Number : 156007 — Changsha, China
• Investigational Site Number : 156008 — Chengdu, China
• Investigational Site Number : 156005 — Chongqing, China
• Investigational Site Number : 156012 — Guangzhou, China
• Investigational Site Number : 156003 — Shanghai, China
• Investigational Site Number : 156004 — Shanghai, China
• Investigational Site Number : 156011 — Shijiazhuang, China
• Investigational Site Number : 156009 — Taiyuan, China
• Investigational Site Number : 233001 — Tallinn, Estonia
• Investigational Site Number : 250001 — Le Kremlin-Bicêtre, France
• Investigational Site Number : 250002 — Lyon, France
• Investigational Site Number : 250003 — Rennes, France
• Investigational Site Number : 250005 — Toulouse, France
• North Central Neurology Associates, PC Site Number : 840003 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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