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Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)

This study is ongoing, but not recruiting participants.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00134563
  Purpose

The purpose of this study is to determine the effects of teriflunomide on: frequency of relapses; accumulation of disability, measured by Expanded Disability Status Scale (EDSS); burden of disease, measured by magnetic resonance imaging (MRI); subject-reported fatigue; and safety and tolerability.

The 2-years double-blind placebo controlled period is followed by a long term open-label extension study with two doses of Teriflunomide.


Condition Intervention Phase
Multiple Sclerosis
Drug: teriflunomide
Phase III

MedlinePlus related topics:   Multiple Sclerosis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Physical Disability in Subjects With Multiple Sclerosis Relapses

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Expanded Disability Status scores assessed every 12 weeks

Secondary Outcome Measures:
  • Cerebral MRI to be performed every 24 weeks

Estimated Enrollment:   1080
Study Start Date:   September 2004

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Multiple sclerosis (MS) subjects,who are ambulatory (EDSS of ≤ 5.5)
  • Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing)
  • Meeting McDonald's criteria for MS diagnosis
  • Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial
  • No relapse onset in the preceding 60 days prior to randomization
  • During the 4 weeks prior to randomization, subjects must have been clinically stable, without adrenocorticotrophic hormone (ACTH) or systemic steroid treatment.
  • Signed informed consent form

Exclusion Criteria:

  • Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
  • Patients with significantly impaired bone marrow function
  • Pregnant or nursing women
  • Alcohol or drug abuse
  • Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
  • Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134563

Show 18 study locations  Show 18 Study Locations

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Principal Investigator:     Paul O'Connor, MD     St. Michael's Hospital, Toronto    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   sanofi-aventis ( ICD )
Study ID Numbers:   EFC6049, LTS6050, HMR1726
First Received:   August 23, 2005
Last Updated:   April 10, 2008
ClinicalTrials.gov Identifier:   NCT00134563
Health Authority:   Canada: Health Canada;   France: Ministry of Health;   Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Sanofi-Aventis:
Multiple Sclerosis  
Relapsing Remitting  
Secondary Progressive  
Progressive Relapsing  

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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