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

NCT02201108 PHASE3 COMPLETED Results posted

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 sponsorGenzyme, a Sanofi Company
PhasePHASE3
StatusCOMPLETED
Enrolment166
Start dateWed Jul 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

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)