Multiple Sclerosis Clinical Trial
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. 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 the disease to get worse.
The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
Eligibility Criteria
Key Inclusion 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:
Must have a 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:
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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There is 1 Location for this study
Gilbert Arizona, , United States
Phoenix Arizona, , United States
San Francisco California, , United States
New Haven Connecticut, , United States
Washington District of Columbia, , United States
Vero Beach Florida, , United States
Atlanta Georgia, , United States
Evanston Illinois, , United States
Palos Heights Illinois, , United States
Fort Wayne Indiana, , United States
Indianapolis Indiana, , United States
Des Moines Iowa, , United States
Wichita Kansas, , United States
Lexington Kentucky, , United States
Brighton Massachusetts, , United States
Hopedale Massachusetts, , United States
Lexington Massachusetts, , United States
Springfield Massachusetts, , United States
Worcester Massachusetts, , United States
Farmington Hills Michigan, , United States
Minneapolis Minnesota, , United States
Columbia Missouri, , United States
St. Louis Missouri, , United States
Henderson Nevada, , United States
Las Vegas Nevada, , United States
Lebanon New Hampshire, , United States
Albany New York, , United States
Staten Island New York, , United States
Raleigh North Carolina, , United States
Dayton Ohio, , United States
Erie Pennsylvania, , United States
Hershey Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
East Providence Rhode Island, , United States
Providence Rhode Island, , United States
San Antonio Texas, , United States
Newport News Virginia, , United States
Wien Virginia, , United States
Seattle Washington, , United States
Camperdown New South Wales, , Australia
Chatswood New South Wales, , Australia
Fitzroy , , Australia
Geelong , , Australia
Heidelberg , , Australia
Kogarah , , Australia
Liverpool , , Australia
Melbourne , , Australia
Newcastle , , Australia
Wien Vienna, , Austria
Graz , , Austria
Innsbruck , , Austria
Linz , , Austria
Antwerpen , , Belgium
Brugge , , Belgium
Charleroi , , Belgium
Diepenbeek , , Belgium
Leuven , , Belgium
Lommel , , Belgium
Sijsele-Damme , , Belgium
Woluwe , , Belgium
Banja Luka Republic of Srpksa, , Bosnia and Herzegovina
Burnaby British Columbia, , Canada
Halifax Nova Scotia, , Canada
Ottawa Ontario, , Canada
Levis Quebec, , Canada
Quebec City Quebec, , Canada
Regina Saskatchewan, , Canada
Montreal , , Canada
Zagreb , , Croatia
Brno , , Czech Republic
Jihlava , , Czech Republic
Opava , , Czech Republic
Ostrava , , Czech Republic
Plzen , , Czech Republic
Praha , , Czech Republic
Teplice , , Czech Republic
Clermont Ferrand , , France
Nice , , France
Paris , , France
Rennes , , France
Bad Neustadt-Saale , , Germany
Berlin , , Germany
Bochum , , Germany
Dusseldorf , , Germany
Essen , , Germany
Gieben , , Germany
Halle , , Germany
Hamburg , , Germany
Hannover , , Germany
Leipzig , , Germany
Minden , , Germany
Munchen , , Germany
Munster , , Germany
Osnabruck , , Germany
Westerstede , , Germany
Athens , , Greece
Ioannina , , Greece
Thessaloniki , , Greece
Guatemala City , , Guatemala
Chenna , , India
Coimbatore , , India
Delhi , , India
Hyderabad , , India
Kolkata , , India
Lucknow , , India
Mangalore , , India
Mumbai , , India
New Delhi , , India
Pune , , India
Ashkelon , , Israel
Beer Yaakov , , Israel
Jerusalem , , Israel
Tel Hashomer , , Israel
Roma , , Italy
Skopje , , Macedonia, The Former Yugoslav Republic of
Guadalajara , , Mexico
Mexico City , , Mexico
San Luis Potosi , , Mexico
Chisinau , , Moldova, Republic of
Kishinev , , Moldova, Republic of
Breda , , Netherlands
Sittard , , Netherlands
Christchurch , , New Zealand
Grafton , , New Zealand
Hamilton , , New Zealand
Bialystok , , Poland
Gdansk , , Poland
Katowice , , Poland
Krakow , , Poland
Poznan , , Poland
Szczecin , , Poland
Warsaw , , Poland
Bucuresti , , Romania
Cluj-Napoca , , Romania
Timisoara , , Romania
Belgrade , , Serbia
Kragujevac , , Serbia
Nis , , Serbia
Novi Sad , , Serbia
Bratislava , , Slovakia
Kosice , , Slovakia
Martin , , Slovakia
Cape Town , , South Africa
Durban , , South Africa
Rosebank , , South Africa
Basel , , Switzerland
St. Gallen , , Switzerland
Zurich , , Switzerland
Kharkiv , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Odessa , , Ukraine
Poltava , , Ukraine
Zaporozhye , , Ukraine
London , , United Kingdom
Newcastle , , United Kingdom
Oxford , , United Kingdom
Sheffield , , United Kingdom
Staffordshire , , United Kingdom
Vienna , , Virgin Islands (U.S.)
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