Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis — TOPIC  

Multiple Sclerosis Clinical Trial

Official title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

Status Active, not recruiting

Clinical Trial Summary

The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives are:

• To demonstrate the effect of teriflunomide, in comparison to placebo, on:

• Reducing conversion to definite multiple sclerosis (DMS)

• Reducing annualized relapse rate (ARR)

• Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)

• Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)

• Proportion of disability-free participants as assessed by the EDSS

• Reducing participant-reported fatigue

• To evaluate the safety and tolerability of teriflunomide

• To evaluate the pharmacokinetics (PK) of teriflunomide

• Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

Clinical Trial Description

The study consists of 4 periods:

• Screening period: up to 4 weeks,

• Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),

• Extension treatment period (without placebo-control): the extension period will continue until teriflunomide is commercially available in participant's country of residence.

• Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per participant is expected to be 116 weeks if he/she does not continue in the extension treatment period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00622700
• Study type: Interventional
• Source: Sanofi
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2008
• Completion date: December 2015