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

NCT02201108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-02-06

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Teriflunomide

Pharmaceutical form:film-coated tablet, Route of administration: oral

DRUG

Placebo

Pharmaceutical form:tablet, Route of administration: oral

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2019-10-25
Completion
2024-07-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Estonia
  • France
  • Greece
  • Israel
  • Lebanon
  • Lithuania
  • Morocco
  • Netherlands
  • North Macedonia
  • Portugal
  • Russia
  • Serbia
  • Spain
  • Tunisia
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201108 on ClinicalTrials.gov