A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2014
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.
Epistemonikos ID: 64f8b49d1458607b99bfe669b0a7a2d058759f5b
First added on: Mar 31, 2022