Multiple Sclerosis Clinical Trial
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Summary
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.
Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.
Other secondary objectives were:
To assess the effect of the two doses of teriflunomide in comparison to placebo on:
Fatigue;
Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
To evaluate the safety and tolerability of teriflunomide.
Full Description
The study consists of:
A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.
The overall treatment period was followed by a 4-week elimination follow-up period.
Eligibility Criteria
Inclusion Criteria:
Relapsing multiple sclerosis,
Two relapses in prior 2 years or one relapse in prior year.
Exclusion Criteria:
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
Pregnant or nursing woman,
Alcohol or drug abuse,
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
Human immunodeficiency virus (HIV) positive,
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 participant's potential participation in a clinical trial.
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There are 171 Locations for this study
Phoenix Arizona, 85060, United States
Tucson Arizona, 85741, United States
Loma Linda California, 92354, United States
Modesto California, 95355, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06430, United States
Maitland Florida, 32761, United States
Ocala Florida, 34474, United States
Ormond Beach Florida, 32174, United States
Sarasota Florida, 34239, United States
St. Petersburg Florida, 33606, United States
Sunrise Florida, 33351, United States
Elk Grove Village Illinois, 60007, United States
Flossmoor Illinois, 60402, United States
Ft Wayne Indiana, 46804, United States
Indianapolis Indiana, 46256, United States
Des Moines Iowa, 50314, United States
Clinton Township Michigan, 48035, United States
Grand Rapids Michigan, 49503, United States
Traverse City Michigan, 49684, United States
Minneapolis Minnesota, 55455, United States
Tupelo Mississippi, 38801, United States
St. Louis Missouri, 63131, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28204, United States
Bismarck North Dakota, 58501, United States
Cincinnati Ohio, 45219, United States
Dayton Ohio, 45409, United States
Tulsa Oklahoma, 74137, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19107, United States
Greenville South Carolina, 29615, United States
Cordova Tennessee, 38018, United States
Nashville Tennessee, 37232, United States
San Antonio Texas, 78229, United States
Bennington Vermont, 05201, United States
Seattle Washington, 98122, United States
Charleston West Virginia, 25301, United States
Bedford Park , 5042, Australia
Chatswood , 2067, Australia
Fitzroy , 3065, Australia
Geelong , 3220, Australia
Heidelberg , 3084, Australia
New Lambton , 2305, Australia
Sydney , 2050, Australia
Wien , 1010, Austria
Grodno , , Belarus
Minsk , 22022, Belarus
Minsk , , Belarus
Minsk , , Belarus
Vitebsk , , Belarus
Brugge , 8000, Belgium
Leuven , 3000, Belgium
Melsbroek , , Belgium
Sijsele-Damme , , Belgium
Gatineau , J9J 0, Canada
Kingston , K7L 2, Canada
Montreal , H1T 2, Canada
Ottawa , K2G 6, Canada
Quebec , G1J 1, Canada
Regina , S4T 1, Canada
Saint John , E2L 3, Canada
Santiago , , Chile
Santiago , , Chile
Viña Del Mar , , Chile
Baotou , 01401, China
Beijing , 10003, China
Beijing , 10005, China
Beijing , 10005, China
Beijing , 10005, China
Beijing , 10006, China
Beijing , 10008, China
Beijing , 10019, China
Beijing , 10073, China
Beijing , 10085, China
Changchun , 13002, China
Chengdu , 61004, China
Guangzhou , 51026, China
Guangzhou , 51063, China
Haikou , 57010, China
Hangzhou , 31001, China
Jinan , 25003, China
Nanjing , 21000, China
Nanjing , 21002, China
Qingdao , 26600, China
Shanghai , 20000, China
Shanghai , 20004, China
Shenyang , 11000, China
Shijiazhuang , 05005, China
Suzhou , 21500, China
Taiyuan , 03000, China
Tianjin , 30005, China
Tianjin , 30021, China
Wenzhou , 32500, China
Wuhan , 43003, China
Xi'An , 71003, China
Xi'An , 71006, China
Brno , 65691, Czech Republic
Ostrava - Poruba , 70852, Czech Republic
Teplice , 415 2, Czech Republic
Tallinn , 10617, Estonia
Tartu , 50406, Estonia
Besancon , 25030, France
Dijon Cedex , 21033, France
Lyon Cedex 03 , 69394, France
Nantes Cedex 01 , 44093, France
Nice Cedex , 06002, France
Nimes , 30029, France
Poissy , 78300, France
Bamberg , 96047, Germany
Bayreuth , 95445, Germany
Berlin , 10713, Germany
Erlangen , 91054, Germany
Gießen , 35385, Germany
Hannover , 30625, Germany
Leipzig , 04157, Germany
Magdeburg , 39120, Germany
Wiesbaden , 65191, Germany
Athens , 11527, Greece
Thessaloniki , 57010, Greece
Monterrey , 64460, Mexico
México , 06726, Mexico
'S Hertogenbosch , 5211 , Netherlands
Breda , 4818 , Netherlands
Groesbeek , 6561 , Netherlands
Nieuwegein , 3435 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Cebu City , , Philippines
Makati City , 1229, Philippines
Manila , , Philippines
Quezon City , 1102, Philippines
Gdansk , 80-80, Poland
Lodz , 90-54, Poland
Lublin , 20-71, Poland
Szczecin , 70-21, Poland
Warszawa 44 , 04-14, Poland
Bacau , 60011, Romania
Brasov , 50012, Romania
Bucuresti , 01058, Romania
Oradea , 41015, Romania
Bratislava 2 , 82606, Slovakia
Bratislava 2 , 82606, Slovakia
Martin , 03659, Slovakia
Presov , 08181, Slovakia
Barcelona , 08035, Spain
Getafe , 28905, Spain
Girona , 17007, Spain
Madrid , 28040, Spain
Sevilla , 41071, Spain
Stockholm , 141 8, Sweden
Stockholm , 171 7, Sweden
Stockholm , 182 8, Sweden
Bangkok-Noi , 10700, Thailand
Bangkok , 10330, Thailand
Manouba , 2010, Tunisia
Sfax , 3029, Tunisia
Tunis , 1006, Tunisia
Tunis , 1007, Tunisia
Edirne , , Turkey
Istanbul , 34147, Turkey
Istanbul , 34390, Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Izmir , 35380, Turkey
Kocaeli , 41380, Turkey
Manisa , , Turkey
Samsun , , Turkey
Trabzon , 61080, Turkey
Chernihiv , 14025, Ukraine
Dnipropetrovsk , 49027, Ukraine
Donetsk , 83003, Ukraine
Donetsk , 83099, Ukraine
Ivano-Frankovsk , 76008, Ukraine
Kharkiv , 61018, Ukraine
Kharkov , 61068, Ukraine
Kiev , 04050, Ukraine
Kiev , 04112, Ukraine
Kiev , , Ukraine
Lutsk , 43005, Ukraine
Lutsk , 43024, Ukraine
Lviv , 79010, Ukraine
Lviv , 79010, Ukraine
Poltava , 36011, Ukraine
Vinnytsya , 21005, Ukraine
Zaporizhya , 69035, Ukraine
Zaporizhzhia , 69600, Ukraine
Zaporozhye , 69000, Ukraine
Edinburgh , EH4 2, United Kingdom
Haywards Heath , RH16 , United Kingdom
Irvine , KA12 , United Kingdom
Leeds , LS1 3, United Kingdom
Salford , M6 8H, United Kingdom
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