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

NCT00622700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2017-03-13

Study results available
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Summary

The primary objective was 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 were:

* 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

Conditions

Interventions

DRUG

Teriflunomide

Film-coated tablet Oral administration

DRUG

Placebo

Film-coated tablet Oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-12-31
Completion
2016-02-29

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622700 on ClinicalTrials.gov