Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Status:
Completed
Trial end date:
2021-10-06
Target enrollment:
Participant gender:
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.