Multiple Sclerosis Clinical Trial

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Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

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Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

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Full Description

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

View Eligibility Criteria

Eligibility Criteria

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1417

Study ID:

NCT00451451

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 2 Locations for this study

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Birmingham Alabama, , United States
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Cullman Alabama, , United States
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Huntsville Alabama, , United States
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Phoenix Arizona, , United States
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La Jolla California, , United States
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Loma Linda California, , United States
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Pasadena California, , United States
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Sacramento California, , United States
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Walnut Creek California, , United States
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Boulder Colorado, , United States
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Colorado Springs Colorado, , United States
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Fort Collins Colorado, , United States
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Maitland Florida, , United States
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Miami Florida, , United States
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Naples Florida, , United States
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Pompano Beach Florida, , United States
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Sarasota Florida, , United States
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St. Petersburg Florida, , United States
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Tallahassee Florida, , United States
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Tampa Florida, , United States
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Augusta Georgia, , United States
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Columbus Georgia, , United States
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Meridan Idaho, , United States
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Indianapolis Indiana, , United States
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Kansas City Kansas, , United States
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Louisville Kentucky, , United States
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Shreveport Louisiana, , United States
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Baltimore Maryland, , United States
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Boston Massachusetts, , United States
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Clinton Township Michigan, , United States
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Grand Rapids Michigan, , United States
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Dover New Hampshire, , United States
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Lebanon New Hampshire, , United States
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Freehold New Jersey, , United States
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Teaneck New Jersey, , United States
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Amherst New York, , United States
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Buffalo New York, , United States
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Cedarhurst New York, , United States
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Mineola New York, , United States
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Patchogue New York, , United States
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Plainview New York, , United States
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Staten Island New York, , United States
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Stony Brook New York, , United States
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Charlotte North Carolina, , United States
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Winston-Salem North Carolina, , United States
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Bellevue Ohio, , United States
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Cleveland Ohio, , United States
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Columbus Ohio, , United States
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Edmond Oklahoma, , United States
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Eugene Oregon, , United States
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Medford Oregon, , United States
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Portland Oregon, , United States
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Philadelphia Pennsylvania, , United States
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Pittsburgh Pennsylvania, , United States
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Souderton Pennsylvania, , United States
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Cordova Tennessee, , United States
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Franklin Tennessee, , United States
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Knoxville Tennessee, , United States
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Memphis Tennessee, , United States
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Nashville Tennessee, , United States
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Dallas Texas, , United States
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Galveston Texas, , United States
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Houston Texas, , United States
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Round Rock Texas, , United States
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San Antonio Texas, , United States
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Salt Lake City Utah, , United States
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Burlington Vermont, , United States
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Richmond Virginia, , United States
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Seattle Washington, , United States
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Tacoma Washington, , United States
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Madison Wisconsin, , United States
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Milwaukee Wisconsin, , United States
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Gomel , , Belarus
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Minsk , , Belarus
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Vitebsk , , Belarus
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Lommel , , Belgium
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Sijsele-Damme , , Belgium
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Woluwe , , Belgium
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Tuzla B&H Federation, , Bosnia and Herzegovina
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Banja Luka Republic Srpska, , Bosnia and Herzegovina
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Sarajevo B&H Federation , , Bosnia and Herzegovina
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Plovdiv , , Bulgaria
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Rousse , , Bulgaria
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Sofia , , Bulgaria
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Stara Zagora , , Bulgaria
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Varna , , Bulgaria
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Edmonton , , Canada
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London , , Canada
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Montreal , , Canada
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Osijek , , Canada
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San Jose , , Costa Rica
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Rijeka , , Croatia
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Zagreb , , Croatia
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Ostrava-Moravska , , Czech Republic
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Ostrava , , Czech Republic
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Praha , , Czech Republic
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Kuressaare , , Estonia
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Parnu , , Estonia
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Tallinn , , Estonia
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Tartu , , Estonia
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Caen , , France
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Dijon , , France
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Marseille , , France
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Montpellier , , France
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Nancy , , France
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Nimes , , France
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Strasbourg , , France
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Bamberg , , Germany
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Bayreuth , , Germany
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Berg Starnberger , , Germany
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Berlin , , Germany
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Dusseldorf , , Germany
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Erbach , , Germany
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Erlangen , , Germany
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Giessen , , Germany
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Halle (Saale) , , Germany
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Hanburg , , Germany
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Heidelberg , , Germany
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Koln , , Germany
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Magdeburg , , Germany
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Marburg , , Germany
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Munchen , , Germany
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Regensburg , , Germany
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Schwerin , , Germany
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Athens , , Greece
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Larisa , , Greece
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Patra , , Greece
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Thessaloniki , , Greece
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Ahmedabad , , India
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Bangalore , , India
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Calicut , , India
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Chandigarh , , India
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Chennai , , India
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Cochin , , India
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Coimbatore , , India
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Kochi , , India
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Kolkata , , India
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Lucknow , , India
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Ludhiana , , India
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Mangalore , , India
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Mumbai , , India
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New Delhi , , India
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Pune , , India
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Cork , , Ireland
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Dublin , , Ireland
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Galway , , Ireland
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Holon , , Israel
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Safed , , Israel
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Riga , , Latvia
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Skopje , , Macedonia, The Former Yugoslav Republic of
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Guadalajara Jal, , Mexico
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Morelia Michoacan, , Mexico
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Monterrey Nuevo Leon, , Mexico
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Aguascalientes , , Mexico
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Guadalajara , , Mexico
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Mexico DF , 10700, Mexico
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Mexico DF , , Mexico
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Mexico , 14000, Mexico
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Monterray , , Mexico
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Chisinau , , Moldova, Republic of
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Kishinev , , Moldova, Republic of
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Hamilton , , New Zealand
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Bialystok , , Poland
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Gdansk , , Poland
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Katowice , , Poland
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Lodz , , Poland
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Lublin , , Poland
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Poznan , , Poland
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Szczecin , , Poland
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Warsaw , , Poland
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Warszawa , , Poland
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Wroclaw , , Poland
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Guaynabo , , Puerto Rico
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Bucuresti , , Romania
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Iasi , , Romania
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Oradea , , Romania
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Tirgu Mures , , Romania
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Tirgu-Mures , , Romania
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Belgrade , , Serbia
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Kragujevac , , Serbia
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Nis , , Serbia
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Novi Sad , , Serbia
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Kosice , , Slovakia
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Martin , , Slovakia
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Barcelona , , Spain
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Bilbao , , Spain
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Cordoba , , Spain
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Gandia , , Spain
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Madrid , , Spain
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Malaga , , Spain
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Santiago de Compostela , , Spain
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Sevilla , , Spain
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Kharkiv , , Ukraine
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Kyiv , , Ukraine
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Lviv , , Ukraine
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Odessa , , Ukraine
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Poltava , , Ukraine
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Simferopol , , Ukraine
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Zaporozhye , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1417

Study ID:

NCT00451451

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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