Last updated on October 2017

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


Brief description of study

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. Secondary Objectives: - To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function. - To evaluate the safety and tolerability of teriflunomide in comparison to placebo. - To evaluate the pharmacokinetics (PK) of teriflunomide.

Detailed Study Description

- A screening period up to 4 weeks - A double-blind treatment period of up to 96 weeks for each patient - An open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, ie, up to a maximum of 192 weeks after randomization - A follow-up period of 4 weeks for patients discontinuing treatment Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from patients and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14mg adult-equivalent dose for the rest of the study. Patients experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomisation.

Clinical Study Identifier: NCT02201108

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