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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00835770




Registration number
NCT00835770
Ethics application status
Date submitted
2/02/2009
Date registered
3/02/2009
Date last updated
6/08/2018

Titles & IDs
Public title
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Scientific title
A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 0 0
2008-004753-14
Secondary ID [2] 0 0
109MS303
Universal Trial Number (UTN)
Trial acronym
ENDORSE
Linked study record

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

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

Experimental: BG00012 plus placebo - In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.

Experimental: BG00012 - In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.

Experimental: BG00012 plus placebo - In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.

Experimental: BG00012 - In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.

Experimental: BG00012 plus placebo - In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.

Experimental: BG00012 - In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.


Treatment: Drugs: dimethyl fumarate
BG00012 capsules

Treatment: Drugs: Placebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.

Treatment: Drugs: dimethyl fumarate
BG00012 capsules

Treatment: Drugs: Placebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.

Treatment: Drugs: dimethyl fumarate
BG00012 capsules

Treatment: Drugs: Placebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.

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

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events
Timepoint [1] 0 0
Day 1 up to atleast 8 years
Primary outcome [2] 0 0
Number of Participants with Adverse Events
Timepoint [2] 0 0
Day 1 up to atleast 8 years
Primary outcome [3] 0 0
Number of Participants with Adverse Events
Timepoint [3] 0 0
Day 1 up to atleast 8 years
Secondary outcome [1] 0 0
Number of Participants Who Had Relapses
Timepoint [1] 0 0
Day 1 up to atleast 8 years
Secondary outcome [2] 0 0
Annualized Relapse Rate (ARR)
Timepoint [2] 0 0
Day 1 up to atleast 8 years
Secondary outcome [3] 0 0
Change from Baseline in the Expanded Disability Status Scale (EDSS) for atleast 8 years - Progression of disability is defined as at least a 1.0 point increase on the EDSS from baseline EDSS 1.0 that is sustained for 24 weeks or at least a 1.5 point increase on the EDSS from baseline EDSS =0 that is sustained for 24 weeks. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Timepoint [3] 0 0
Day 1 up to atleast 8 years
Secondary outcome [4] 0 0
Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [4] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [5] 0 0
Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [5] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [6] 0 0
Number and volume of T1 hypointense lesions
Timepoint [6] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [7] 0 0
Change from Baseline in Brain atrophy
Timepoint [7] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [8] 0 0
Summary of Magnetization Transfer Ratio (MTR) - MTR is used in neuroradiology to highlight abnormalities in brain structures
Timepoint [8] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [9] 0 0
Change from Baseline in EQ-5D Health Survey (EQ-5D) for atleast 8 years - EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), a health status rating scale, and demographic questions.
Timepoint [9] 0 0
Day 1 to atleast 8 years
Secondary outcome [10] 0 0
Change from baseline in SF-36® Health Survey (SF-36) for atleast 8 years - The SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
Timepoint [10] 0 0
Day 1 to atleast 8 years
Secondary outcome [11] 0 0
Change from Baseline in Visual Function test scores for atleast 8 years
Timepoint [11] 0 0
Day 1 to atleast 8 years
Secondary outcome [12] 0 0
Number of Participants Who Had Relapses
Timepoint [12] 0 0
Day 1 up to atleast 8 years
Secondary outcome [13] 0 0
Annualized Relapse Rate (ARR)
Timepoint [13] 0 0
Day 1 up to atleast 8 years
Secondary outcome [14] 0 0
Change from Baseline in the Expanded Disability Status Scale (EDSS) for atleast 8 years - Progression of disability is defined as at least a 1.0 point increase on the EDSS from baseline EDSS 1.0 that is sustained for 24 weeks or at least a 1.5 point increase on the EDSS from baseline EDSS =0 that is sustained for 24 weeks. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Timepoint [14] 0 0
Day 1 up to atleast 8 years
Secondary outcome [15] 0 0
Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [15] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [16] 0 0
Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [16] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [17] 0 0
Number and volume of T1 hypointense lesions
Timepoint [17] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [18] 0 0
Change from Baseline in Brain atrophy
Timepoint [18] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [19] 0 0
Summary of Magnetization Transfer Ratio (MTR) - MTR is used in neuroradiology to highlight abnormalities in brain structures
Timepoint [19] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [20] 0 0
Change from Baseline in EQ-5D Health Survey (EQ-5D) for atleast 8 years - EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), a health status rating scale, and demographic questions.
Timepoint [20] 0 0
Day 1 to atleast 8 years
Secondary outcome [21] 0 0
Change from baseline in SF-36® Health Survey (SF-36) for atleast 8 years - The SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
Timepoint [21] 0 0
Day 1 to atleast 8 years
Secondary outcome [22] 0 0
Change from Baseline in Visual Function test scores for atleast 8 years
Timepoint [22] 0 0
Day 1 to atleast 8 years
Secondary outcome [23] 0 0
Number of Participants Who Had Relapses
Timepoint [23] 0 0
Day 1 up to atleast 8 years
Secondary outcome [24] 0 0
Annualized Relapse Rate (ARR)
Timepoint [24] 0 0
Day 1 up to atleast 8 years
Secondary outcome [25] 0 0
Change from Baseline in the Expanded Disability Status Scale (EDSS) for atleast 8 years - Progression of disability is defined as at least a 1.0 point increase on the EDSS from baseline EDSS 1.0 that is sustained for 24 weeks or at least a 1.5 point increase on the EDSS from baseline EDSS =0 that is sustained for 24 weeks. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Timepoint [25] 0 0
Day 1 up to atleast 8 years
Secondary outcome [26] 0 0
Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [26] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [27] 0 0
Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI)
Timepoint [27] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [28] 0 0
Number and volume of T1 hypointense lesions
Timepoint [28] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [29] 0 0
Change from Baseline in Brain atrophy
Timepoint [29] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [30] 0 0
Summary of Magnetization Transfer Ratio (MTR) - MTR is used in neuroradiology to highlight abnormalities in brain structures
Timepoint [30] 0 0
Day 1 upto approximately 7.5 years from study start date.
Secondary outcome [31] 0 0
Change from Baseline in EQ-5D Health Survey (EQ-5D) for atleast 8 years - EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), a health status rating scale, and demographic questions.
Timepoint [31] 0 0
Day 1 to atleast 8 years
Secondary outcome [32] 0 0
Change from baseline in SF-36® Health Survey (SF-36) for atleast 8 years - The SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
Timepoint [32] 0 0
Day 1 to atleast 8 years
Secondary outcome [33] 0 0
Change from Baseline in Visual Function test scores for atleast 8 years
Timepoint [33] 0 0
Day 1 to atleast 8 years

Eligibility
Key inclusion criteria
Key

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

Key
Minimum age
19 Years
Maximum age
58 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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,VIC
Recruitment hospital [1] 0 0
Research Site - Kogarah
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Box Hill
Recruitment hospital [5] 0 0
Research Site - Chatswood
Recruitment hospital [6] 0 0
Research Site - Fitzroy
Recruitment hospital [7] 0 0
Research Site - Geelong
Recruitment hospital [8] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
3084 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
2067 - Chatswood
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
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
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Linz
Country [31] 0 0
Austria
State/province [31] 0 0
Vienna
Country [32] 0 0
Belarus
State/province [32] 0 0
Gomel
Country [33] 0 0
Belarus
State/province [33] 0 0
Vitebsk
Country [34] 0 0
Belarus
State/province [34] 0 0
Minsk
Country [35] 0 0
Belgium
State/province [35] 0 0
Antwerpen
Country [36] 0 0
Belgium
State/province [36] 0 0
Brugge
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Charleroi
Country [39] 0 0
Belgium
State/province [39] 0 0
Damme
Country [40] 0 0
Belgium
State/province [40] 0 0
Diepenbeek
Country [41] 0 0
Belgium
State/province [41] 0 0
Hechtel-Eksel
Country [42] 0 0
Belgium
State/province [42] 0 0
Leuven
Country [43] 0 0
Belgium
State/province [43] 0 0
Lodelinsart
Country [44] 0 0
Belgium
State/province [44] 0 0
Sint-Truiden
Country [45] 0 0
Bosnia and Herzegovina
State/province [45] 0 0
Tuzla
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Ruse
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Sofia
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Canada
State/province [49] 0 0
Edmonton
Country [50] 0 0
Canada
State/province [50] 0 0
London
Country [51] 0 0
Canada
State/province [51] 0 0
Montreal
Country [52] 0 0
Canada
State/province [52] 0 0
Nova Scotia
Country [53] 0 0
Canada
State/province [53] 0 0
Ottawa
Country [54] 0 0
Canada
State/province [54] 0 0
Regina
Country [55] 0 0
Croatia
State/province [55] 0 0
Zagreb
Country [56] 0 0
Czechia
State/province [56] 0 0
Brno
Country [57] 0 0
Czechia
State/province [57] 0 0
Jihlava
Country [58] 0 0
Czechia
State/province [58] 0 0
Moravska Ostrava
Country [59] 0 0
Czechia
State/province [59] 0 0
Olomouc
Country [60] 0 0
Czechia
State/province [60] 0 0
Opava
Country [61] 0 0
Czechia
State/province [61] 0 0
Ostrava - Vítkovice
Country [62] 0 0
Czechia
State/province [62] 0 0
Prague
Country [63] 0 0
Czechia
State/province [63] 0 0
Teplice
Country [64] 0 0
Estonia
State/province [64] 0 0
Parnu
Country [65] 0 0
Estonia
State/province [65] 0 0
Tallinn
Country [66] 0 0
Estonia
State/province [66] 0 0
Tartu
Country [67] 0 0
France
State/province [67] 0 0
Amiens
Country [68] 0 0
France
State/province [68] 0 0
Caen
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France
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Clermont-Ferrand
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France
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Dijon
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France
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Lille
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Lyon
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France
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Marseille
Country [74] 0 0
France
State/province [74] 0 0
Montpellier
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France
State/province [75] 0 0
Nancy
Country [76] 0 0
France
State/province [76] 0 0
Nice
Country [77] 0 0
France
State/province [77] 0 0
Paris
Country [78] 0 0
France
State/province [78] 0 0
Rennes
Country [79] 0 0
France
State/province [79] 0 0
Strasbourg
Country [80] 0 0
Germany
State/province [80] 0 0
Bavaria
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Germany
State/province [81] 0 0
Ibbenbueren
Country [82] 0 0
Germany
State/province [82] 0 0
Bayreuth
Country [83] 0 0
Germany
State/province [83] 0 0
Berlin
Country [84] 0 0
Germany
State/province [84] 0 0
Bochum
Country [85] 0 0
Germany
State/province [85] 0 0
Dresden
Country [86] 0 0
Germany
State/province [86] 0 0
Dusseldorf
Country [87] 0 0
Germany
State/province [87] 0 0
Erbach
Country [88] 0 0
Germany
State/province [88] 0 0
Erlangen
Country [89] 0 0
Germany
State/province [89] 0 0
Essen
Country [90] 0 0
Germany
State/province [90] 0 0
Halle
Country [91] 0 0
Germany
State/province [91] 0 0
Hamburg
Country [92] 0 0
Germany
State/province [92] 0 0
Hannover
Country [93] 0 0
Germany
State/province [93] 0 0
Koeln
Country [94] 0 0
Germany
State/province [94] 0 0
Leipzig
Country [95] 0 0
Germany
State/province [95] 0 0
Magdeburg
Country [96] 0 0
Germany
State/province [96] 0 0
Marburg
Country [97] 0 0
Germany
State/province [97] 0 0
Minden
Country [98] 0 0
Germany
State/province [98] 0 0
Munich (München)
Country [99] 0 0
Germany
State/province [99] 0 0
Münster
Country [100] 0 0
Germany
State/province [100] 0 0
Osnabrück
Country [101] 0 0
Germany
State/province [101] 0 0
Regensburg
Country [102] 0 0
Germany
State/province [102] 0 0
Westerstede
Country [103] 0 0
Greece
State/province [103] 0 0
Athens
Country [104] 0 0
Greece
State/province [104] 0 0
Thessaloniki
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India
State/province [105] 0 0
Ahmedabad
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India
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Bangalore
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India
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Chandigarh
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India
State/province [108] 0 0
Hyderabad
Country [109] 0 0
India
State/province [109] 0 0
Kolkata
Country [110] 0 0
India
State/province [110] 0 0
Ludhiana
Country [111] 0 0
India
State/province [111] 0 0
Mangalore
Country [112] 0 0
India
State/province [112] 0 0
Mumbai
Country [113] 0 0
India
State/province [113] 0 0
New Delhi
Country [114] 0 0
India
State/province [114] 0 0
Pune
Country [115] 0 0
Ireland
State/province [115] 0 0
Dublin
Country [116] 0 0
Israel
State/province [116] 0 0
Ashkelon
Country [117] 0 0
Israel
State/province [117] 0 0
Jerusalem
Country [118] 0 0
Israel
State/province [118] 0 0
Safed
Country [119] 0 0
Italy
State/province [119] 0 0
Roma
Country [120] 0 0
Latvia
State/province [120] 0 0
Riga
Country [121] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [121] 0 0
Skopje
Country [122] 0 0
Mexico
State/province [122] 0 0
Guadalajara
Country [123] 0 0
Mexico
State/province [123] 0 0
Mexico
Country [124] 0 0
Mexico
State/province [124] 0 0
Morelia
Country [125] 0 0
Mexico
State/province [125] 0 0
San Luis Potosi
Country [126] 0 0
Moldova, Republic of
State/province [126] 0 0
Chisinau
Country [127] 0 0
Netherlands
State/province [127] 0 0
Breda
Country [128] 0 0
Netherlands
State/province [128] 0 0
Geleen
Country [129] 0 0
New Zealand
State/province [129] 0 0
Auckland
Country [130] 0 0
New Zealand
State/province [130] 0 0
Christchurch
Country [131] 0 0
New Zealand
State/province [131] 0 0
Hamilton
Country [132] 0 0
Poland
State/province [132] 0 0
Bialystok
Country [133] 0 0
Poland
State/province [133] 0 0
Gdansk
Country [134] 0 0
Poland
State/province [134] 0 0
Katowice
Country [135] 0 0
Poland
State/province [135] 0 0
Krakow
Country [136] 0 0
Poland
State/province [136] 0 0
Lublin
Country [137] 0 0
Poland
State/province [137] 0 0
Lódz
Country [138] 0 0
Poland
State/province [138] 0 0
Olsztyn
Country [139] 0 0
Poland
State/province [139] 0 0
Plewiska
Country [140] 0 0
Poland
State/province [140] 0 0
Poznan
Country [141] 0 0
Poland
State/province [141] 0 0
Szczecin
Country [142] 0 0
Poland
State/province [142] 0 0
Warszawa
Country [143] 0 0
Poland
State/province [143] 0 0
Wroclaw
Country [144] 0 0
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Stoke on Trent

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00835770
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