Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
NCT ID: NCT01487096
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2001-04-30
2003-03-31
Brief Summary
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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.
Detailed Description
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* a 4-week screening period,
* a 36-week double-blind treatment period,
* a 6-week post-treatment follow-up period.
Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo (for teriflunomide),
* two tablets once daily for 1 week then,
* one tablet once daily for 35 weeks.
Placebo (placebo for teriflunomide)
film-coated tablet
oral administration
Teriflunomide 7 mg
Teriflunomide 7 mg:
* two tablets once daily for 1 week then,
* one tablet once daily for 35 weeks.
Teriflunomide
film-coated tablet
oral administration
Teriflunomide 14 mg
Teriflunomide 14 mg:
* two tablets once daily for 1 week then,
* one tablet once daily for 35 weeks.
Teriflunomide
film-coated tablet
oral administration
Interventions
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Teriflunomide
film-coated tablet
oral administration
Placebo (placebo for teriflunomide)
film-coated tablet
oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale \[EDSS\] score less or equal to 6;
* Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
* Screening magnetic resonance imaging \[MRI\] scan fulfilling the criteria for a diagnosis of MS.
Exclusion Criteria
* Pregnant or nursing woman;
* Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
* Prior treatment with interferon \[IFN\], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
* 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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Director
Role: STUDY_DIRECTOR
Clinical Science & Operation - sanofi-aventis
Locations
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Canada
Toronto, Ontario, Canada
sanofi-aventis France
Lyon, , France
Countries
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References
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O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. doi: 10.1212/01.wnl.0000203121.04509.31.
Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
Other Identifiers
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HMR1726D/2001
Identifier Type: -
Identifier Source: org_study_id