Multiple Sclerosis Clinical Trial

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BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

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Summary

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

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Full Description

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key Exclusion Criteria:

Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1736

Study ID:

NCT00835770

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 243 Locations for this study

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Birmingham Alabama, 35294, United States
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Huntsville Alabama, 35801, United States
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Mesa Arizona, 85206, United States
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Phoenix Arizona, 85013, United States
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Loma Linda California, 92354, United States
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Boulder Colorado, 80304, United States
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Fort Collins Colorado, 80528, United States
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North Haven Connecticut, 06473, United States
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Washington District of Columbia, 20007, United States
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Maitland Florida, 32751, United States
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Miami Florida, 33136, United States
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Naples Florida, 34102, United States
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Sarasota Florida, 34239, United States
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Tampa Florida, 33612, United States
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Atlanta Georgia, 30309, United States
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Atlanta Georgia, 30327, United States
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Evanston Illinois, 60201, United States
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Fort Wayne Indiana, 46845, United States
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Kansas City Kansas, 66160, United States
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Wichita Kansas, 67206, United States
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Shreveport Louisiana, 71103, United States
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Baltimore Maryland, 21201, United States
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Boston Massachusetts, 02135, United States
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Boston Massachusetts, 02215, United States
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Farmington Hills Michigan, 48334, United States
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Minneapolis Minnesota, 55414, United States
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Chesterfield Missouri, 63017, United States
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Saint Louis Missouri, 63104, United States
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Albany New York, 12206, United States
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Amherst New York, 14226, United States
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Buffalo New York, 14203, United States
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Patchogue New York, 11772, United States
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Charlotte North Carolina, 28204, United States
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Raleigh North Carolina, 27607, United States
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Bellevue Ohio, 44811, United States
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Cleveland Ohio, 44195, United States
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Columbus Ohio, 43221, United States
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Dayton Ohio, 45417, United States
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Medford Oregon, 97504, United States
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Portland Oregon, 97225, United States
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Philadelphia Pennsylvania, 19104, United States
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Philadelphia Pennsylvania, 19140, United States
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Pittsburgh Pennsylvania, 15213, United States
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Rumford Rhode Island, 02916, United States
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Cordova Tennessee, 38018, United States
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Knoxville Tennessee, 37922, United States
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Houston Texas, 77030, United States
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Newport News Virginia, 23601, United States
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Issaquah Washington, 98029, United States
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Madison Wisconsin, 53792, United States
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Kogarah New South Wales, 2217, Australia
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New Lambton Heights New South Wales, 2305, Australia
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Melbourne Victoria, 3084, Australia
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Box Hill , 3128, Australia
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Chatswood , 2067, Australia
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Fitzroy , 3065, Australia
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Geelong , 3220, Australia
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Sydney , 2000, Australia
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Graz , 8036, Austria
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Linz , 4021, Austria
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Vienna , 1090, Austria
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Belarus Gomel, 24602, Belarus
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Belarus Vitebsk, 21002, Belarus
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Minsk , 22011, Belarus
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Minsk , 22011, Belarus
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Antwerpen , 2020, Belgium
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Brugge , 8000, Belgium
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Brussels , 1200, Belgium
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Charleroi , 6000, Belgium
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Damme , 8340, Belgium
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Diepenbeek , 3590, Belgium
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Hechtel-Eksel , 3940, Belgium
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Leuven , 3000, Belgium
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Lodelinsart , 6042, Belgium
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Sint-Truiden , 3800, Belgium
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Tuzla , 75000, Bosnia and Herzegovina
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Ruse , 7002, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1309, Bulgaria
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Sofia , 1431, Bulgaria
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Lévis Quebec, G6V 3, Canada
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Edmonton , T6G 2, Canada
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London , N6A 5, Canada
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Montreal , H3A 2, Canada
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Nova Scotia , B3H 4, Canada
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Ottawa , K2G 6, Canada
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Regina , S4T 7, Canada
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Zagreb , 10000, Croatia
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Brno , 656 9, Czechia
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Jihlava , 586 3, Czechia
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Moravska Ostrava , 702 0, Czechia
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Olomouc , 775 2, Czechia
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Opava , 746 0, Czechia
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Ostrava - Vítkovice , 70300, Czechia
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Prague , 128 0, Czechia
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Prague , 150 0, Czechia
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Teplice , 415 0, Czechia
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Parnu , 80010, Estonia
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Tallinn , 10138, Estonia
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Tallinn , 10617, Estonia
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Tartu , 51014, Estonia
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Amiens , 80054, France
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Caen , 14033, France
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Clermont-Ferrand , 63003, France
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Dijon , 21033, France
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Lille , 59037, France
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Lyon , 69394, France
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Marseille , 13385, France
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Montpellier , 34090, France
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Nancy , 54035, France
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Nice , 06002, France
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Paris , 75019, France
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Rennes , 35033, France
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Strasbourg , 67000, France
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Berg Bavaria, 82335, Germany
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Steinfurt Ibbenbueren, 49477, Germany
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Bayreuth , 95445, Germany
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Berlin , 10437, Germany
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Berlin , 10625, Germany
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Berlin , 10961, Germany
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Berlin , 12099, Germany
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Berlin , 12163, Germany
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Berlin , 13347, Germany
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Bochum , 44791, Germany
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Dresden , 01307, Germany
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Dusseldorf , 40212, Germany
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Erbach , 64711, Germany
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Erlangen , 91054, Germany
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Essen , 45257, Germany
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Halle , 06120, Germany
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Hamburg , 20099, Germany
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Hamburg , 20246, Germany
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Hamburg , 22083, Germany
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Hannover , 30171, Germany
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Hannover , 30625, Germany
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Koeln , 50935, Germany
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Leipzig , 04103, Germany
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Magdeburg , 39120, Germany
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Marburg , 35043, Germany
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Minden , 32429, Germany
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Munich (München) , 81675, Germany
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Münster , 48149, Germany
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Osnabrück , 49076, Germany
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Regensburg , 93053, Germany
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Westerstede , 26655, Germany
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Athens , 11527, Greece
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Thessaloniki , 54636, Greece
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Thessaloniki , 57010, Greece
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Ahmedabad , 38000, India
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Bangalore , 56005, India
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Chandigarh , 16001, India
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Hyderabad , 50008, India
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Kolkata , 70005, India
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Kolkata , 70006, India
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Ludhiana , 14100, India
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Ludhiana , 14100, India
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Mangalore , 57500, India
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Mumbai , 40005, India
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New Delhi , 11001, India
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New Delhi , 11002, India
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New Delhi , 11006, India
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Pune , 41100, India
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Pune , 41100, India
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Dublin , DUBLI, Ireland
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Ashkelon , 78278, Israel
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Jerusalem , 91120, Israel
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Safed , 13100, Israel
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Roma , 00189, Italy
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Riga , LV-10, Latvia
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Guadalajara , 44610, Mexico
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Mexico , 03310, Mexico
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Mexico , 06700, Mexico
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Mexico , 06720, Mexico
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Morelia , 58000, Mexico
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San Luis Potosi , 78240, Mexico
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Chisinau , 2001, Moldova, Republic of
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Chisinau , 2028, Moldova, Republic of
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Breda , 4818 , Netherlands
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Geleen , 6162 , Netherlands
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Auckland , 1023, New Zealand
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Christchurch , 8011, New Zealand
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Hamilton , 3204, New Zealand
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Skopje , 1000, North Macedonia
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Bialystok , 15-27, Poland
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Bialystok , 15-40, Poland
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Gdansk , 80-29, Poland
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Gdansk , 80-80, Poland
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Gdansk , 80-95, Poland
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Katowice , 40-59, Poland
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Katowice , 40-75, Poland
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Krakow , 31-50, Poland
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Lublin , 20-95, Poland
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Lódz , 90-15, Poland
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Olsztyn , 10-56, Poland
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Plewiska , 62-06, Poland
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Poznan , 60-35, Poland
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Poznan , 60-53, Poland
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Szczecin , 70-21, Poland
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Szczecin , 71-25, Poland
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Warszawa , 02-09, Poland
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Warszawa , 02-50, Poland
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Warszawa , 02-95, Poland
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Wroclaw , 50-55, Poland
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Guaynabo , 00968, Puerto Rico
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Bucuresti , 01146, Romania
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Bucuresti , 02012, Romania
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Bucuresti , 02210, Romania
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Bucuresti , 05009, Romania
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Cluj-Napoca , 40001, Romania
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Timisoara , 30073, Romania
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Târgu Mures , 54013, Romania
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Belgrade , 11000, Serbia
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Kragujevac , 34000, Serbia
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Nis , 18000, Serbia
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Novi Sad , 21000, Serbia
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Bratislava , 81369, Slovakia
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Bratislava , 82606, Slovakia
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Martin , 03659, Slovakia
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Cape Town , 7925, South Africa
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Durban , 4001, South Africa
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Barcelona , 08035, Spain
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Córdoba , 14011, Spain
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Madrid , 28040, Spain
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Malaga , 29010, Spain
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Sevilla , 41009, Spain
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Basel , 4031, Switzerland
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St. Gallen , 9007, Switzerland
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Zurich , 8091, Switzerland
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Ivano-Frankivsk , 76018, Ukraine
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Kharkiv , 61068, Ukraine
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Kharkiv , 61103, Ukraine
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Kyiv , 03110, Ukraine
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Kyiv , 04112, Ukraine
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Lviv , 79010, Ukraine
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Odessa , 65117, Ukraine
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Poltava , 36011, Ukraine
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Vinnytsia , 21005, Ukraine
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Zaporizhzhia , 69600, Ukraine
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London , E1 2E, United Kingdom
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London , E1 4A, United Kingdom
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London , SE5 9, United Kingdom
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London , W6 8R, United Kingdom
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Newcastle upon Tyne , NE1 4, United Kingdom
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Oxford , OX3 9, United Kingdom
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Sheffield , S10 2, United Kingdom
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Stoke on Trent , ST4 6, United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1736

Study ID:

NCT00835770

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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