The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00420212




Registration number
NCT00420212
Ethics application status
Date submitted
8/01/2007
Date registered
11/01/2007
Date last updated
26/01/2015

Titles & IDs
Public title
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
109MS301
Universal Trial Number (UTN)
Trial acronym
DEFINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG00012
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Participants received two placebo capsules orally three times daily (TID)

Experimental: BG00012 240 mg Twice Daily (BID) - Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)

Experimental: BG00012 240 mg 3 Times Daily (TID) - Participants received two 120 mg BG00012 capsules orally three times daily (TID)


Treatment: Drugs: BG00012


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
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"
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Chatswood
Recruitment hospital [3] 0 0
Research Site - Fitzroy
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - Kogarah
Recruitment hospital [7] 0 0
Research Site - Liverpool
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Newcastle
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Chatswood
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Geelong
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Liverpool
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Newcastle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Austria
State/province [27] 0 0
Graz
Country [28] 0 0
Austria
State/province [28] 0 0
Innsbruck
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Brugge
Country [32] 0 0
Belgium
State/province [32] 0 0
Charleroi
Country [33] 0 0
Belgium
State/province [33] 0 0
Diepenbeek
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Lommel
Country [36] 0 0
Belgium
State/province [36] 0 0
Sijsele-Damme
Country [37] 0 0
Belgium
State/province [37] 0 0
Woluwe
Country [38] 0 0
Bosnia and Herzegovina
State/province [38] 0 0
Republic of Srpksa
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Nova Scotia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Saskatchewan
Country [44] 0 0
Canada
State/province [44] 0 0
Montreal
Country [45] 0 0
Croatia
State/province [45] 0 0
Zagreb
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Brno
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Jihlava
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Opava
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Ostrava
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Plzen
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Praha
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Teplice
Country [53] 0 0
France
State/province [53] 0 0
Clermont Ferrand
Country [54] 0 0
France
State/province [54] 0 0
Nice
Country [55] 0 0
France
State/province [55] 0 0
Paris
Country [56] 0 0
France
State/province [56] 0 0
Rennes
Country [57] 0 0
Germany
State/province [57] 0 0
Bad Neustadt-Saale
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Bochum
Country [60] 0 0
Germany
State/province [60] 0 0
Dusseldorf
Country [61] 0 0
Germany
State/province [61] 0 0
Essen
Country [62] 0 0
Germany
State/province [62] 0 0
Gieben
Country [63] 0 0
Germany
State/province [63] 0 0
Halle
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Germany
State/province [65] 0 0
Hannover
Country [66] 0 0
Germany
State/province [66] 0 0
Leipzig
Country [67] 0 0
Germany
State/province [67] 0 0
Minden
Country [68] 0 0
Germany
State/province [68] 0 0
Munchen
Country [69] 0 0
Germany
State/province [69] 0 0
Munster
Country [70] 0 0
Germany
State/province [70] 0 0
Osnabruck
Country [71] 0 0
Germany
State/province [71] 0 0
Westerstede
Country [72] 0 0
Greece
State/province [72] 0 0
Athens
Country [73] 0 0
Greece
State/province [73] 0 0
Ioannina
Country [74] 0 0
Greece
State/province [74] 0 0
Thessaloniki
Country [75] 0 0
Guatemala
State/province [75] 0 0
Guatemala City
Country [76] 0 0
India
State/province [76] 0 0
Chenna
Country [77] 0 0
India
State/province [77] 0 0
Coimbatore
Country [78] 0 0
India
State/province [78] 0 0
Delhi
Country [79] 0 0
India
State/province [79] 0 0
Hyderabad
Country [80] 0 0
India
State/province [80] 0 0
Kolkata
Country [81] 0 0
India
State/province [81] 0 0
Lucknow
Country [82] 0 0
India
State/province [82] 0 0
Mangalore
Country [83] 0 0
India
State/province [83] 0 0
Mumbai
Country [84] 0 0
India
State/province [84] 0 0
New Delhi
Country [85] 0 0
India
State/province [85] 0 0
Pune
Country [86] 0 0
Israel
State/province [86] 0 0
Ashkelon
Country [87] 0 0
Israel
State/province [87] 0 0
Beer Yaakov
Country [88] 0 0
Israel
State/province [88] 0 0
Jerusalem
Country [89] 0 0
Israel
State/province [89] 0 0
Tel Hashomer
Country [90] 0 0
Italy
State/province [90] 0 0
Roma
Country [91] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [91] 0 0
Skopje
Country [92] 0 0
Mexico
State/province [92] 0 0
Guadalajara
Country [93] 0 0
Mexico
State/province [93] 0 0
Mexico City
Country [94] 0 0
Mexico
State/province [94] 0 0
San Luis Potosi
Country [95] 0 0
Moldova, Republic of
State/province [95] 0 0
Chisinau
Country [96] 0 0
Moldova, Republic of
State/province [96] 0 0
Kishinev
Country [97] 0 0
Netherlands
State/province [97] 0 0
Breda
Country [98] 0 0
Netherlands
State/province [98] 0 0
Sittard
Country [99] 0 0
New Zealand
State/province [99] 0 0
Christchurch
Country [100] 0 0
New Zealand
State/province [100] 0 0
Grafton
Country [101] 0 0
New Zealand
State/province [101] 0 0
Hamilton
Country [102] 0 0
Poland
State/province [102] 0 0
Bialystok
Country [103] 0 0
Poland
State/province [103] 0 0
Gdansk
Country [104] 0 0
Poland
State/province [104] 0 0
Katowice
Country [105] 0 0
Poland
State/province [105] 0 0
Krakow
Country [106] 0 0
Poland
State/province [106] 0 0
Poznan
Country [107] 0 0
Poland
State/province [107] 0 0
Szczecin
Country [108] 0 0
Poland
State/province [108] 0 0
Warsaw
Country [109] 0 0
Romania
State/province [109] 0 0
Bucuresti
Country [110] 0 0
Romania
State/province [110] 0 0
Cluj-Napoca
Country [111] 0 0
Romania
State/province [111] 0 0
Timisoara
Country [112] 0 0
Serbia
State/province [112] 0 0
Belgrade
Country [113] 0 0
Serbia
State/province [113] 0 0
Kragujevac
Country [114] 0 0
Serbia
State/province [114] 0 0
Nis
Country [115] 0 0
Serbia
State/province [115] 0 0
Novi Sad
Country [116] 0 0
Slovakia
State/province [116] 0 0
Bratislava
Country [117] 0 0
Slovakia
State/province [117] 0 0
Kosice
Country [118] 0 0
Slovakia
State/province [118] 0 0
Martin
Country [119] 0 0
South Africa
State/province [119] 0 0
Cape Town
Country [120] 0 0
South Africa
State/province [120] 0 0
Durban
Country [121] 0 0
South Africa
State/province [121] 0 0
Rosebank
Country [122] 0 0
Switzerland
State/province [122] 0 0
Basel
Country [123] 0 0
Switzerland
State/province [123] 0 0
St. Gallen
Country [124] 0 0
Switzerland
State/province [124] 0 0
Zurich
Country [125] 0 0
Ukraine
State/province [125] 0 0
Kharkiv
Country [126] 0 0
Ukraine
State/province [126] 0 0
Kyiv
Country [127] 0 0
Ukraine
State/province [127] 0 0
Lviv
Country [128] 0 0
Ukraine
State/province [128] 0 0
Odessa
Country [129] 0 0
Ukraine
State/province [129] 0 0
Poltava
Country [130] 0 0
Ukraine
State/province [130] 0 0
Zaporozhye
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Newcastle
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Oxford
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Sheffield
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Staffordshire
Country [136] 0 0
Virgin Islands (U.S.)
State/province [136] 0 0
Vienna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00420212
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications