Relapsing-Remitting Multiple Sclerosis Clinical Trial
— DEFINEOfficial title:
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
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.
Status | Completed |
Enrollment | 1234 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Camperdown | New South Wales |
Australia | Research Site | Chatswood | New South Wales |
Australia | Research Site | Fitzroy | |
Australia | Research Site | Geelong | |
Australia | Research Site | Heidelberg | |
Australia | Research Site | Kogarah | |
Australia | Research Site | Liverpool | |
Australia | Research Site | Melbourne | |
Australia | Research Site | Newcastle | |
Austria | Research Site | Graz | |
Austria | Research Site | Innsbruck | |
Austria | Research Site | Linz | |
Austria | Research Site | Wien | Vienna |
Belgium | Research Site | Antwerpen | |
Belgium | Research Site | Brugge | |
Belgium | Research Site | Charleroi | |
Belgium | Research Site | Diepenbeek | |
Belgium | Research Site | Leuven | |
Belgium | Research Site | Lommel | |
Belgium | Research Site | Sijsele-Damme | |
Belgium | Research Site | Woluwe | |
Bosnia and Herzegovina | Research Site | Banja Luka | Republic of Srpksa |
Canada | Research Site | Burnaby | British Columbia |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Levis | Quebec |
Canada | Research Site | Montreal | |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Quebec City | Quebec |
Canada | Research Site | Regina | Saskatchewan |
Croatia | Research Site | Zagreb | |
Czech Republic | Research Site | Brno | |
Czech Republic | Research Site | Jihlava | |
Czech Republic | Research Site | Opava | |
Czech Republic | Research Site | Ostrava | |
Czech Republic | Research Site | Plzen | |
Czech Republic | Research Site | Praha | |
Czech Republic | Research Site | Teplice | |
France | Research Site | Clermont Ferrand | |
France | Research Site | Nice | |
France | Research Site | Paris | |
France | Research Site | Rennes | |
Germany | Research Site | Bad Neustadt-Saale | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bochum | |
Germany | Research Site | Dusseldorf | |
Germany | Research Site | Essen | |
Germany | Research Site | Gieben | |
Germany | Research Site | Halle | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hannover | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Minden | |
Germany | Research Site | Munchen | |
Germany | Research Site | Munster | |
Germany | Research Site | Osnabruck | |
Germany | Research Site | Westerstede | |
Greece | Research Site | Athens | |
Greece | Research Site | Ioannina | |
Greece | Research Site | Thessaloniki | |
Guatemala | Research Site | Guatemala City | |
India | Research Site | Chenna | |
India | Research Site | Coimbatore | |
India | Research Site | Delhi | |
India | Research Site | Hyderabad | |
India | Research Site | Kolkata | |
India | Research Site | Lucknow | |
India | Research Site | Mangalore | |
India | Research Site | Mumbai | |
India | Research Site | New Delhi | |
India | Research Site | Pune | |
Israel | Research Site | Ashkelon | |
Israel | Research Site | Beer Yaakov | |
Israel | Research Site | Jerusalem | |
Israel | Research Site | Tel Hashomer | |
Italy | Research Site | Roma | |
Macedonia, The Former Yugoslav R | Research Site | Skopje | |
Mexico | Research Site | Guadalajara | |
Mexico | Research Site | Mexico City | |
Mexico | Research Site | San Luis Potosi | |
Moldova, Republic of | Research Site | Chisinau | |
Moldova, Republic of | Research Site | Kishinev | |
Netherlands | Research Site | Breda | |
Netherlands | Research Site | Sittard | |
New Zealand | Research Site | Christchurch | |
New Zealand | Research Site | Grafton | |
New Zealand | Research Site | Hamilton | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Gdansk | |
Poland | Research Site | Katowice | |
Poland | Research Site | Krakow | |
Poland | Research Site | Poznan | |
Poland | Research Site | Szczecin | |
Poland | Research Site | Warsaw | |
Romania | Research Site | Bucuresti | |
Romania | Research Site | Cluj-Napoca | |
Romania | Research Site | Timisoara | |
Serbia | Research Site | Belgrade | |
Serbia | Research Site | Kragujevac | |
Serbia | Research Site | Nis | |
Serbia | Research Site | Novi Sad | |
Slovakia | Research Site | Bratislava | |
Slovakia | Research Site | Kosice | |
Slovakia | Research Site | Martin | |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Durban | |
South Africa | Research Site | Rosebank | |
Switzerland | Research Site | Basel | |
Switzerland | Research Site | St. Gallen | |
Switzerland | Research Site | Zurich | |
Ukraine | Research Site | Kharkiv | |
Ukraine | Research Site | Kyiv | |
Ukraine | Research Site | Lviv | |
Ukraine | Research Site | Odessa | |
Ukraine | Research Site | Poltava | |
Ukraine | Research Site | Zaporozhye | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Newcastle | |
United Kingdom | Research Site | Oxford | |
United Kingdom | Research Site | Sheffield | |
United Kingdom | Research Site | Staffordshire | |
United States | Research Site | Albany | New York |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Brighton | Massachusetts |
United States | Research Site | Columbia | Missouri |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Des Moines | Iowa |
United States | Research Site | East Providence | Rhode Island |
United States | Research Site | Erie | Pennsylvania |
United States | Research Site | Evanston | Illinois |
United States | Research Site | Farmington Hills | Michigan |
United States | Research Site | Fort Wayne | Indiana |
United States | Research Site | Gilbert | Arizona |
United States | Research Site | Henderson | Nevada |
United States | Research Site | Hershey | Pennsylvania |
United States | Research Site | Hopedale | Massachusetts |
United States | Research Site | Indianapolis | Indiana |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Lebanon | New Hampshire |
United States | Research Site | Lexington | Massachusetts |
United States | Research Site | Lexington | Kentucky |
United States | Research Site | Minneapolis | Minnesota |
United States | Research Site | New Haven | Connecticut |
United States | Research Site | Newport News | Virginia |
United States | Research Site | Palos Heights | Illinois |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Providence | Rhode Island |
United States | Research Site | Raleigh | North Carolina |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Francisco | California |
United States | Research Site | Seattle | Washington |
United States | Research Site | Springfield | Massachusetts |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Staten Island | New York |
United States | Research Site | Vero Beach | Florida |
United States | Research Site | Washington | District of Columbia |
United States | Research Site | Wichita | Kansas |
United States | Research Site | Wien | Virginia |
United States | Research Site | Worcester | Massachusetts |
Virgin Islands (U.S.) | Research Site | Vienna |
Lead Sponsor | Collaborator |
---|---|
Biogen |
United States, Virgin Islands (U.S.), Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, France, Germany, Greece, Guatemala, India, Israel, Italy, Macedonia, The Former Yugoslav Republic of, Mexico, Moldova, Republic of, Netherlands, New Zealand, Poland, Romania, Serbia, Slovakia, South Africa, Switzerland, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Subjects Relapsed | A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution. | 2 years | No |
Secondary | Number of New or Newly Enlarging T2 Hyperintense Lesions | The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume | 2 years | No |
Secondary | Number of Gadolinium-enhancing T1-weighted Lesions | The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group. | 2 years | No |
Secondary | Number of Subjects With Gadolinium (Gd)-Enhancing Lesions | Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions" | 2 years | No |
Secondary | Annualized Relapse Rate | A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (= 2.0 vs. >2.0), age (<40 versus =40 years), region, and the number of relapses in the 1 year prior to enrollment. | 2 years | No |
Secondary | Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) | The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as = 1.0 point increase in subjects with a baseline EDSS of =1.0, or a =1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed =12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution. | 2 years | No |
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