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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.
First Received: August 23, 2005   Last Updated: September 24, 2008   History of Changes
Sponsor: 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 LTS6050 with two doses of Teriflunomide.


Condition Intervention Phase
Multiple Sclerosis
Drug: teriflunomide (HMR1726)
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), 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 Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Expanded Disability Status [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral MRI [ Time Frame: every 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1080
Study Start Date: September 2004
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
7 mg
Drug: teriflunomide (HMR1726)
oral administration once daily
2: Experimental
14 mg
Drug: teriflunomide (HMR1726)
oral administration once daily
3: Placebo Comparator Drug: placebo
oral administration once daily

  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

  Hide Study Locations
Locations
United States, New Jersey
Sanofi-aventis
Bridgewater, New Jersey, United States
Austria
Sanofi-Aventis Austria
Vienna, Austria
Canada
sanofi-aventis, Canada
Laval, Canada
Chile
Sanofi-aventis
Santiago de Chile, Chile
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
Denmark
sanofi-aventis Denmark
Horsholm, Denmark
Estonia
Sanofi-aventis Administrative Office
Tallinn, Estonia
Finland
sanofi-aventis Finland
Helsinki, Finland
France
sanofi-aventis France
Paris, France
Germany
Sanofi-Aventis Deutschland GmbH
Berlin, Germany
Italy
Sanofi-aventis
Milano, Italy
Netherlands
Sanofi-aventis
Gouda, Netherlands
Norway
Sanofi-aventis
Lysaker, Norway
Poland
sanofi-aventis Poland
Warszawa, Poland
Portugal
Sanofi-aventis
Porto Salvo, Portugal
Russian Federation
Sanofi-aventis
Moscow, Russian Federation
Sweden
Sanofi-aventis
Bromma, Sweden
Switzerland
Sanofi-Aventis Switzerland
Geneva, Switzerland
Turkey
sanofi-aventis Turkey
Istanbul, Turkey
Ukraine
Sanofi-aventis Administrative Office
Kiev, Ukraine
United Kingdom, Surrey
sanofi-aventis UK
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Principal Investigator: Paul O'Connor, MD St. Michael's Hospital, Toronto
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( ICD )
Study ID Numbers: EFC6049, EudraCT 2004-000555-42, HMR1726D/3001, LTS6050
Study First Received: August 23, 2005
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00134563     History of Changes
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

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System
Recurrence

ClinicalTrials.gov processed this record on November 27, 2009