MedTrace Logo

Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

NCT01487096 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2012-10-04

No results posted yet for this study

Summary

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

* To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
* To investigate the pharmacokinetic and pharmacodynamic relationships.

Conditions

Interventions

DRUG

Teriflunomide

film-coated tablet oral administration

DRUG

Placebo (placebo for teriflunomide)

film-coated tablet oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Director · Clinical Science & Operation - sanofi-aventis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • Canada
  • France

Study Locations

More Related Trials

Entities

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 NCT01487096 on ClinicalTrials.gov