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Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
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.
Details
| Lead sponsor | Genzyme, a Sanofi Company |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 166 |
| Start date | Wed Jul 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Multiple Sclerosis
Interventions
- Teriflunomide
- Placebo
Countries
Lebanon, Tunisia, Netherlands, Russia, Belgium, Estonia, Lithuania, Bulgaria, Morocco, Portugal, United States, France, Greece, Serbia, Israel, Canada, Spain, Ukraine, United Kingdom, China, North Macedonia, Turkey (Türkiye)