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BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE)

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ClinicalTrials.gov Identifier: NCT00835770
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Interventions Drug: dimethyl fumarate
Drug: Placebo
Enrollment 1736
Recruitment Details Participants were enrolled at 298 investigative sites from 03 February 2009 to 08 November 2019.
Pre-assignment Details The study included participants who completed studies NCT00420212 and NCT00451451. A total of 1736 participants were treated in the open label phase extension study NCT00835770, out of which 759 completed the study.
Arm/Group Title BG00012 240 mg BID BG00012 240 mg TID
Hide Arm/Group Description Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years. Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, three times a day (TID) for up to 8 years.
Period Title: Overall Study
Started 868 868
Completed 384 375
Not Completed 484 493
Reason Not Completed
MS Relapse             17             23
MS Progression             14             9
Adverse Event             113             124
Lost to Follow-up             22             19
Consent Withdrawn             144             156
Investigator Decision             42             42
Participant Non-Compliance             11             9
Death             4             6
Other             115             104
Other             2             1
Arm/Group Title BG00012 240 mg BID BG00012 240 mg TID Total
Hide Arm/Group Description Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Total of all reporting groups
Overall Number of Baseline Participants 868 868 1736
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for ethnicity was not evaluated in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 868 participants 868 participants 1736 participants
39.6  (8.93) 40.1  (9.23) 39.8  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 868 participants 868 participants 1736 participants
Female
616
  71.0%
596
  68.7%
1212
  69.8%
Male
252
  29.0%
272
  31.3%
524
  30.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 868 participants 868 participants 1736 participants
White
285
  32.8%
309
  35.6%
594
  34.2%
Black or African American
10
   1.2%
16
   1.8%
26
   1.5%
Asian
82
   9.4%
80
   9.2%
162
   9.3%
Other
32
   3.7%
24
   2.8%
56
   3.2%
Not Reported Due To Confidentiality Regulations
459
  52.9%
439
  50.6%
898
  51.7%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame Day 1 up to Week 561
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Arm/Group Title BG00012 240 mg BID BG00012 240 mg TID
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
Overall Number of Participants Analyzed 868 868
Measure Type: Count of Participants
Unit of Measure: Participants
824
  94.9%
814
  93.8%
2.Secondary Outcome
Title Percentage of Participants Who Had Relapses
Hide Description Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
Time Frame Day 1 up to Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Measure Type: Number
Unit of Measure: percentage of participants
40 41 34 36 31 31
3.Secondary Outcome
Title Annualized Relapse Rate (ARR)
Hide Description The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.
Time Frame Day 1 up to Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Measure Type: Number
Unit of Measure: relapses per participant-years
0.159 0.179 0.200 0.199 0.184 0.212
4.Secondary Outcome
Title Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
Hide Description EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.
Time Frame Baseline, Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 499 participants 502 participants 249 participants 248 participants 118 participants 118 participants
2.44  (1.251) 2.43  (1.144) 2.50  (1.135) 2.54  (1.218) 2.57  (1.249) 2.68  (1.231)
Change at Week 384 Number Analyzed 226 participants 219 participants 90 participants 98 participants 42 participants 50 participants
0.28  (1.160) 0.26  (1.213) 0.37  (1.328) 0.53  (1.278) 0.39  (1.217) 0.49  (1.319)
5.Secondary Outcome
Title Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: lesions
Week 48 Number Analyzed 191 participants 195 participants 83 participants 78 participants 41 participants 48 participants
0.4  (1.87) 0.4  (1.29) 0.2  (0.66) 0.3  (1.14) 0.5  (1.19) 0.4  (1.14)
Week 96 Number Analyzed 183 participants 186 participants 77 participants 75 participants 39 participants 46 participants
0.4  (1.77) 0.4  (1.28) 0.1  (0.38) 0.2  (0.82) 0.6  (1.33) 0.3  (0.73)
Week 144 Number Analyzed 156 participants 159 participants 66 participants 60 participants 32 participants 41 participants
0.3  (1.66) 0.4  (1.30) 0.2  (0.44) 0.1  (0.29) 0.5  (2.48) 0.3  (1.59)
Week 192 Number Analyzed 144 participants 149 participants 59 participants 55 participants 33 participants 38 participants
0.4  (2.02) 0.5  (1.85) 0.5  (1.72) 0.3  (0.96) 0.2  (0.60) 0.6  (2.01)
Week 240 Number Analyzed 135 participants 134 participants 55 participants 53 participants 29 participants 34 participants
0.5  (3.14) 0.5  (2.29) 0.2  (0.50) 0.2  (0.51) 0.2  (0.58) 0.3  (0.75)
Week 288 Number Analyzed 90 participants 97 participants 30 participants 32 participants 6 participants 16 participants
0.2  (0.74) 0.5  (1.81) 0.1  (0.40) 0.7  (2.76) 0.0  (0.00) 0.3  (0.77)
6.Secondary Outcome
Title Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: millimeter cube (mm^3)
Baseline Number Analyzed 209 participants 220 participants 104 participants 99 participants 47 participants 60 participants
31.7  (179.28) 48.6  (205.43) 96.0  (260.79) 142.5  (459.76) 37.1  (138.82) 41.7  (116.55)
Week 48 Number Analyzed 190 participants 197 participants 83 participants 77 participants 40 participants 48 participants
59.6  (526.51) 70.0  (366.63) 18.8  (91.47) 25.3  (108.19) 42.5  (123.67) 42.7  (148.11)
Week 96 Number Analyzed 182 participants 185 participants 77 participants 73 participants 38 participants 46 participants
49.1  (245.14) 56.1  (271.29) 27.7  (204.80) 13.3  (67.01) 64.3  (183.16) 22.3  (60.83)
Week 144 Number Analyzed 155 participants 160 participants 66 participants 59 participants 31 participants 41 participants
44.1  (291.14) 47.0  (169.68) 18.8  (66.15) 3.8  (25.03) 42.6  (142.55) 92.9  (397.69)
Week 192 Number Analyzed 143 participants 148 participants 59 participants 54 participants 32 participants 38 participants
39.1  (217.89) 54.5  (251.31) 45.8  (156.88) 19.9  (79.19) 12.0  (40.56) 55.1  (169.16)
Week 240 Number Analyzed 134 participants 133 participants 55 participants 52 participants 28 participants 34 participants
96.8  (650.06) 69.3  (374.67) 21.7  (77.87) 14.1  (45.22) 17.5  (46.19) 17.1  (48.41)
Week 288 Number Analyzed 89 participants 97 participants 30 participants 31 participants 6 participants 16 participants
18.2  (93.28) 53.1  (250.87) 7.9  (30.09) 230.2  (1092.11) 0.0  (0.00) 34.1  (102.87)
7.Secondary Outcome
Title Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The T2 lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: lesions
Week 48 Number Analyzed 198 participants 201 participants 84 participants 81 participants 42 participants 50 participants
1.6  (4.07) 2.2  (6.15) 2.7  (4.96) 2.4  (5.45) 3.4  (6.57) 2.1  (3.83)
Week 96 Number Analyzed 191 participants 192 participants 78 participants 77 participants 40 participants 47 participants
3.4  (8.35) 4.1  (10.01) 3.8  (7.24) 2.9  (6.78) 4.9  (8.51) 3.4  (5.13)
Week 144 Number Analyzed 163 participants 168 participants 67 participants 63 participants 35 participants 44 participants
4.2  (9.81) 5.2  (10.01) 4.0  (7.27) 4.3  (10.12) 5.7  (9.45) 5.2  (9.68)
Week 192 Number Analyzed 151 participants 155 participants 61 participants 56 participants 33 participants 40 participants
5.8  (14.04) 7.5  (15.14) 5.6  (10.09) 5.6  (14.19) 5.5  (9.94) 5.6  (13.35)
Week 240 Number Analyzed 139 participants 142 participants 55 participants 55 participants 30 participants 37 participants
7.4  (17.09) 9.5  (20.33) 8.2  (14.87) 7.7  (17.89) 6.8  (11.74) 7.5  (16.76)
Week 288 Number Analyzed 123 participants 123 participants 45 participants 49 participants 26 participants 32 participants
8.2  (18.53) 12.4  (28.23) 7.5  (13.89) 10.4  (22.05) 8.9  (15.04) 6.0  (8.90)
8.Secondary Outcome
Title Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The T2 lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: mm^3
Baseline Number Analyzed 209 participants 220 participants 104 participants 99 participants 47 participants 60 participants
10231.9  (11214.17) 10408.3  (12166.80) 8883.7  (8570.10) 10806.3  (12060.05) 12628.9  (11258.69) 13044.4  (14608.50)
Week 48 Number Analyzed 194 participants 199 participants 84 participants 78 participants 40 participants 50 participants
9951.9  (10750.15) 9849.6  (10986.36) 8992.1  (7952.13) 10114.5  (10121.61) 11160.7  (9565.55) 12979.0  (14415.86)
Week 96 Number Analyzed 187 participants 190 participants 78 participants 74 participants 38 participants 47 participants
10331.3  (11359.81) 10434.0  (12201.38) 8645.2  (7787.60) 9985.7  (10715.73) 11318.1  (9873.73) 13974.1  (15432.10)
Week 144 Number Analyzed 162 participants 167 participants 67 participants 61 participants 34 participants 44 participants
9930.1  (10686.26) 10280.7  (11324.58) 8829.4  (7482.93) 9792.3  (9842.28) 10188.5  (8064.09) 12949.7  (14036.15)
Week 192 Number Analyzed 149 participants 154 participants 61 participants 55 participants 32 participants 40 participants
9837.7  (10845.04) 10760.0  (11987.16) 9077.6  (7794.52) 10576.3  (12029.26) 10421.9  (8773.41) 11671.5  (13124.47)
Week 240 Number Analyzed 138 participants 141 participants 55 participants 54 participants 29 participants 37 participants
10611.2  (11633.95) 11087.5  (12464.90) 9711.1  (8709.46) 10591.4  (11613.26) 11009.9  (9551.94) 12254.4  (13732.10)
Week 288 Number Analyzed 121 participants 122 participants 45 participants 49 participants 26 participants 32 participants
9611.8  (9447.18) 9800.8  (11279.84) 8819.8  (8866.90) 10537.6  (10684.47) 11586.3  (9728.19) 10404.8  (12245.75)
9.Secondary Outcome
Title Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The T1 hypointense lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: lesions
Week 48 Number Analyzed 183 participants 184 participants 79 participants 76 participants 41 participants 48 participants
0.8  (2.13) 1.0  (2.37) 1.8  (3.81) 1.7  (3.71) 2.0  (4.22) 1.3  (2.64)
Week 96 Number Analyzed 171 participants 178 participants 75 participants 72 participants 39 participants 45 participants
1.7  (3.63) 1.9  (3.91) 1.8  (3.33) 2.1  (5.00) 3.0  (5.85) 1.9  (3.44)
Week 144 Number Analyzed 148 participants 155 participants 63 participants 53 participants 32 participants 41 participants
2.0  (4.61) 2.8  (5.19) 2.0  (3.69) 2.6  (7.02) 3.1  (6.20) 2.9  (5.19)
Week 192 Number Analyzed 141 participants 145 participants 58 participants 53 participants 33 participants 38 participants
2.9  (7.03) 3.4  (6.79) 2.9  (5.12) 3.8  (10.71) 3.3  (6.74) 3.0  (7.14)
Week 240 Number Analyzed 134 participants 136 participants 55 participants 53 participants 29 participants 34 participants
3.4  (8.25) 4.8  (9.39) 4.0  (7.52) 4.9  (13.30) 4.0  (8.06) 4.2  (10.20)
Week 288 Number Analyzed 88 participants 94 participants 30 participants 32 participants 6 participants 16 participants
2.7  (5.72) 5.9  (12.02) 4.5  (7.38) 3.6  (4.51) 1.0  (1.10) 5.6  (6.81)
10.Secondary Outcome
Title Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Hide Description The T1 hypointense lesions was evaluated using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: mm^3
Baseline Number Analyzed 209 participants 220 participants 104 participants 99 participants 47 participants 60 participants
3640.1  (5598.31) 3447.3  (4900.96) 2754.2  (3552.30) 3623.1  (5549.13) 3204.3  (4221.55) 3572.6  (4915.24)
Week 48 Number Analyzed 190 participants 197 participants 83 participants 77 participants 40 participants 48 participants
3829.5  (5824.26) 3715.5  (5112.21) 2891.9  (3034.00) 3936.0  (5271.89) 3271.0  (4157.24) 3743.3  (5374.24)
Week 96 Number Analyzed 183 participants 186 participants 77 participants 73 participants 38 participants 46 participants
3841.2  (5682.74) 3853.7  (5428.66) 2921.0  (3327.93) 3849.4  (5167.13) 3510.4  (4672.80) 3949.7  (5018.63)
Week 144 Number Analyzed 157 participants 164 participants 67 participants 58 participants 33 participants 42 participants
3767.4  (4969.23) 4074.0  (5413.85) 3145.6  (3366.27) 4006.9  (5062.08) 3499.2  (4198.50) 4126.1  (5695.44)
Week 192 Number Analyzed 145 participants 149 participants 60 participants 54 participants 32 participants 38 participants
3834.9  (4942.19) 4177.4  (5301.68) 3385.4  (3575.44) 4330.0  (5136.67) 3592.0  (4069.39) 4089.3  (4996.13)
Week 240 Number Analyzed 135 participants 137 participants 55 participants 52 participants 28 participants 34 participants
4038.6  (5145.85) 4238.2  (5248.84) 3406.4  (3936.73) 3823.9  (4274.82) 3503.4  (3933.75) 4057.7  (5223.62)
Week 288 Number Analyzed 113 participants 121 participants 40 participants 45 participants 20 participants 29 participants
3603.3  (4394.60) 3973.1  (5202.05) 3350.6  (4140.34) 4187.5  (4835.43) 3264.9  (3639.91) 2959.1  (3918.62)
11.Secondary Outcome
Title Percent Change From Baseline in Brain Atrophy
Hide Description Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 48 Number Analyzed 162 participants 162 participants 56 participants 64 participants 33 participants 42 participants
-1.206  (1.1006) -1.263  (1.0848) -1.487  (1.3086) -1.320  (1.4021) -1.496  (1.1316) -1.414  (1.1882)
Change at Week 96 Number Analyzed 144 participants 145 participants 50 participants 56 participants 30 participants 37 participants
-1.372  (1.1382) -1.500  (1.0893) -1.589  (1.3630) -1.775  (1.7191) -1.883  (1.2383) -1.810  (1.4556)
Change at Week 144 Number Analyzed 122 participants 133 participants 44 participants 49 participants 28 participants 36 participants
-1.708  (1.4109) -1.876  (1.2604) -2.139  (1.5884) -2.353  (1.7897) -2.386  (1.3168) -2.252  (2.2124)
Change at Week 192 Number Analyzed 114 participants 120 participants 41 participants 45 participants 29 participants 36 participants
-2.138  (1.6831) -2.117  (1.4000) -2.230  (1.7755) -2.476  (1.7062) -2.645  (1.2284) -2.417  (2.0486)
Change at Week 240 Number Analyzed 92 participants 95 participants 37 participants 40 participants 18 participants 26 participants
-2.313  (1.6309) -2.253  (1.3721) -2.271  (1.4817) -2.593  (1.9043) -2.249  (1.2985) -2.790  (2.2188)
Change at Week 288 Number Analyzed 71 participants 72 participants 25 participants 30 participants 15 participants 23 participants
-2.216  (1.5744) -2.271  (1.2193) -2.470  (1.6757) -2.849  (1.9648) -2.657  (1.7051) -2.496  (1.3699)
12.Secondary Outcome
Title Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Hide Description Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 213 222 105 103 49 60
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 48 Number Analyzed 126 participants 118 participants 49 participants 56 participants 20 participants 23 participants
-0.325  (5.4932) -0.383  (4.8621) 1.034  (7.3548) -0.567  (4.4766) -0.081  (13.6416) -0.334  (1.5103)
Change at Week 96 Number Analyzed 118 participants 113 participants 46 participants 50 participants 20 participants 20 participants
-0.427  (6.6493) -0.532  (4.9880) 1.630  (7.6584) -0.947  (7.0771) -4.269  (12.6065) 0.215  (1.4270)
Change at Week 144 Number Analyzed 103 participants 107 participants 45 participants 37 participants 19 participants 24 participants
-0.042  (9.2548) 0.509  (7.2692) 1.525  (8.6421) 1.411  (12.2825) -4.460  (10.3887) 3.119  (8.1676)
Change at Week 192 Number Analyzed 100 participants 100 participants 42 participants 41 participants 25 participants 23 participants
1.038  (10.8680) 0.955  (8.6105) 3.012  (9.3831) 3.103  (13.0046) 1.384  (15.7611) 3.841  (10.8600)
Change at Week 240 Number Analyzed 91 participants 90 participants 40 participants 42 participants 23 participants 20 participants
-0.002  (15.6190) 1.647  (8.3094) 3.213  (9.6621) 4.108  (13.8103) 2.959  (16.8386) 0.673  (25.9962)
Change at Week 288 Number Analyzed 65 participants 71 participants 19 participants 25 participants 5 participants 14 participants
0.002  (4.0206) -0.391  (4.6415) -0.666  (2.0741) -0.622  (2.2922) -0.466  (0.9410) -1.114  (2.4539)
13.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
Hide Description The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.
Time Frame Baseline, Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline: Physical Functioning Score Number Analyzed 494 participants 487 participants 244 participants 240 participants 115 participants 112 participants
68.48  (25.938) 71.78  (24.849) 69.67  (24.481) 67.97  (26.279) 69.10  (25.226) 68.20  (25.370)
Change at Week 384: Physical Functioning Score Number Analyzed 236 participants 215 participants 90 participants 97 participants 43 participants 48 participants
0.73  (21.972) -4.79  (24.641) -7.37  (22.253) -6.89  (23.194) -6.19  (21.719) -6.25  (28.350)
Baseline: Role-Physical Score Number Analyzed 494 participants 486 participants 244 participants 238 participants 114 participants 112 participants
56.46  (41.254) 58.42  (41.280) 56.35  (40.896) 59.87  (41.747) 55.26  (40.390) 53.57  (42.029)
Change at Week 384: Role-Physical Score Number Analyzed 232 participants 215 participants 90 participants 94 participants 43 participants 48 participants
3.20  (48.259) -2.75  (47.283) -10.00  (43.188) -8.24  (53.177) -12.21  (40.595) -1.04  (54.568)
Baseline: Bodily-Pain Score Number Analyzed 494 participants 490 participants 244 participants 240 participants 115 participants 112 participants
69.68  (25.587) 70.42  (24.688) 68.51  (26.163) 69.44  (26.016) 69.30  (25.766) 68.59  (26.102)
Change at Week 384: Bodily-Pain Score Number Analyzed 237 participants 216 participants 90 participants 97 participants 43 participants 48 participants
1.32  (28.525) -1.47  (25.779) -2.92  (23.486) -4.36  (25.935) -3.60  (22.138) -4.46  (33.297)
Baseline: General Health Score Number Analyzed 493 participants 489 participants 240 participants 238 participants 115 participants 110 participants
53.99  (21.563) 55.44  (20.768) 54.45  (18.690) 52.42  (20.028) 51.21  (18.707) 52.58  (19.675)
Change at Week 384: General Health Score Number Analyzed 234 participants 213 participants 86 participants 95 participants 42 participants 47 participants
0.87  (18.744) -2.12  (20.595) -2.28  (16.752) -0.52  (22.035) -5.64  (18.270) 1.21  (21.674)
Baseline: Vitality Score Number Analyzed 492 participants 486 participants 242 participants 239 participants 115 participants 111 participants
50.48  (20.966) 52.21  (19.842) 50.63  (19.130) 50.64  (21.069) 51.30  (19.703) 50.33  (20.019)
Change at Week 384: Vitality Score Number Analyzed 235 participants 214 participants 87 participants 96 participants 41 participants 47 participants
1.11  (19.857) -0.73  (19.033) -4.67  (17.934) 0.40  (20.822) -6.71  (20.236) 1.03  (19.829)
Baseline: Social Functioning Score Number Analyzed 494 participants 490 participants 244 participants 239 participants 115 participants 112 participants
71.46  (24.451) 71.53  (24.394) 69.67  (24.581) 72.23  (24.699) 69.02  (24.688) 69.53  (25.100)
Change at Week 384: Social Functioning Score Number Analyzed 237 participants 216 participants 90 participants 96 participants 43 participants 48 participants
-2.16  (25.575) -3.30  (24.912) -5.69  (22.184) -2.08  (27.724) -10.76  (34.350) -0.52  (25.780)
Baseline: Role-Emotional Score Number Analyzed 491 participants 485 participants 241 participants 238 participants 115 participants 111 participants
64.87  (40.653) 65.57  (40.015) 62.86  (42.715) 62.61  (41.280) 60.29  (41.393) 64.26  (41.854)
Change at Week 384: Role-Emotional Score Number Analyzed 233 participants 214 participants 90 participants 96 participants 43 participants 47 participants
0.43  (49.950) 0.47  (43.513) -12.22  (42.532) 4.17  (44.656) -13.18  (42.501) -3.55  (48.769)
Baseline: Mental Health Score Number Analyzed 492 participants 486 participants 242 participants 239 participants 115 participants 111 participants
65.01  (19.818) 66.24  (19.060) 65.42  (17.658) 65.15  (19.233) 62.30  (17.347) 63.61  (18.414)
Change at Week 384: Mental Health Score Number Analyzed 235 participants 214 participants 87 participants 96 participants 41 participants 47 participants
1.32  (19.715) 2.31  (18.095) -3.91  (19.897) 2.33  (17.524) -0.29  (21.989) -2.06  (20.066)
Baseline: Mental Component Score Number Analyzed 488 participants 480 participants 237 participants 235 participants 114 participants 108 participants
45.40  (11.130) 45.63  (10.272) 45.13  (10.932) 45.31  (10.907) 44.00  (10.702) 45.03  (10.642)
Change at Week 384: Mental Component Score Number Analyzed 226 participants 211 participants 85 participants 92 participants 41 participants 45 participants
0.05  (12.415) 0.87  (10.028) -2.55  (10.328) 1.97  (10.657) -2.59  (12.895) 0.08  (10.328)
Baseline: Physical Component Score Number Analyzed 488 participants 480 participants 237 participants 235 participants 114 participants 108 participants
43.53  (9.884) 44.44  (10.048) 43.74  (9.739) 43.56  (10.267) 43.68  (10.359) 43.15  (10.091)
Change at Week 384: Physical Component Score Number Analyzed 226 participants 211 participants 85 participants 92 participants 41 participants 45 participants
0.55  (9.373) -1.94  (10.532) -2.29  (8.929) -3.25  (9.998) -2.70  (8.860) -1.59  (10.765)
14.Secondary Outcome
Title Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
Hide Description The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.
Time Frame Baseline, Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 488 participants 484 participants 239 participants 239 participants 115 participants 112 participants
0.73  (0.210) 0.73  (0.222) 0.72  (0.223) 0.71  (0.244) 0.71  (0.246) 0.72  (0.189)
Change at Week 384 Number Analyzed 230 participants 212 participants 86 participants 96 participants 42 participants 48 participants
0.01  (0.251) 0.00  (0.233) -0.07  (0.269) 0.00  (0.249) -0.04  (0.253) -0.03  (0.241)
15.Secondary Outcome
Title Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
Hide Description The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.
Time Frame Baseline, Week 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 492 participants 488 participants 243 participants 238 participants 113 participants 112 participants
70.97  (18.460) 70.48  (19.993) 70.40  (17.630) 69.44  (19.907) 66.80  (18.846) 69.07  (20.094)
Change at Week 384 Number Analyzed 235 participants 215 participants 91 participants 95 participants 42 participants 48 participants
-0.48  (19.631) -1.67  (18.855) -7.24  (18.419) -3.17  (22.003) -1.71  (25.330) -4.11  (16.270)
16.Secondary Outcome
Title Change From Baseline in Visual Function Test Scores at Week 384
Hide Description Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.
Time Frame Baseline, Week 384
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Hide Analysis Population Description
ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
Arm/Group Title BG00012 240 mg BID (Prior BG00012 240 mg BID) BG00012 240 mg TID (Prior BG00012 240 mg TID) BG00012 240 mg BID (Prior BG00012 Matched Placebo) BG00012 240 mg TID (Prior BG00012 Matched Placebo) BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Hide Arm/Group Description:
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.
Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed 501 502 249 248 118 118
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline: 100% Chart Number Analyzed 501 participants 502 participants 249 participants 248 participants 118 participants 118 participants
54.7  (7.95) 55.0  (7.84) 55.1  (7.26) 54.8  (7.12) 54.3  (8.26) 55.0  (6.73)
Change at Week 384: 100% Chart Number Analyzed 231 participants 216 participants 87 participants 99 participants 42 participants 50 participants
-0.4  (6.76) -1.9  (6.81) -1.4  (8.48) -1.2  (7.53) -1.6  (8.05) -0.7  (5.17)
Baseline: 2.5% Chart Number Analyzed 501 participants 502 participants 249 participants 248 participants 118 participants 118 participants
32.4  (12.17) 32.6  (11.76) 32.4  (11.42) 32.3  (11.99) 31.8  (12.36) 31.7  (12.41)
Change at Week 384: 2.5% Chart Number Analyzed 231 participants 216 participants 87 participants 99 participants 42 participants 50 participants
-2.4  (10.77) -3.3  (10.43) -1.5  (11.77) -4.9  (11.14) -4.0  (11.90) -2.1  (9.86)
Baseline: 1.25% Chart Number Analyzed 499 participants 502 participants 249 participants 247 participants 118 participants 118 participants
24.1  (12.45) 24.2  (12.28) 23.8  (12.11) 23.7  (12.96) 23.4  (11.76) 22.2  (13.25)
Change at Week 384: 1.25% Chart Number Analyzed 231 participants 216 participants 87 participants 99 participants 42 participants 50 participants
-5.8  (13.39) -6.0  (11.77) -4.1  (13.04) -7.4  (12.42) -6.7  (13.78) -5.0  (12.74)
Time Frame From start of the study up to follow-up (up to Week 561)
Adverse Event Reporting Description Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
 
Arm/Group Title BG00012 240 mg BID BG00012 240 mg TID
Hide Arm/Group Description Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
All-Cause Mortality
BG00012 240 mg BID BG00012 240 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   5/868 (0.58%)   6/868 (0.69%) 
Hide Serious Adverse Events
BG00012 240 mg BID BG00012 240 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   279/868 (32.14%)   272/868 (31.34%) 
Blood and lymphatic system disorders     
Anaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Eosinophilia  1  0/868 (0.00%)  1/868 (0.12%) 
Iron deficiency anaemia  1  2/868 (0.23%)  0/868 (0.00%) 
Leukopenia  1  1/868 (0.12%)  0/868 (0.00%) 
Lymphopenia  1  1/868 (0.12%)  1/868 (0.12%) 
Neutropenia  1  0/868 (0.00%)  1/868 (0.12%) 
Thrombocytopenia  1  1/868 (0.12%)  1/868 (0.12%) 
Cardiac disorders     
Acute coronary syndrome  1  1/868 (0.12%)  0/868 (0.00%) 
Acute myocardial infarction  1  1/868 (0.12%)  0/868 (0.00%) 
Atrial fibrillation  1  2/868 (0.23%)  1/868 (0.12%) 
Cardiac arrest  1  0/868 (0.00%)  2/868 (0.23%) 
Cardiac failure congestive  1  1/868 (0.12%)  0/868 (0.00%) 
Coronary artery disease  1  2/868 (0.23%)  0/868 (0.00%) 
Left ventricular dysfunction  1  1/868 (0.12%)  0/868 (0.00%) 
Mitral valve prolapse  1  1/868 (0.12%)  0/868 (0.00%) 
Myocardial infarction  1  1/868 (0.12%)  5/868 (0.58%) 
Myocardial ischaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Wolff-parkinson-white syndrome  1  1/868 (0.12%)  0/868 (0.00%) 
Congenital, familial and genetic disorders     
Cytogenetic abnormality  1  0/868 (0.00%)  1/868 (0.12%) 
Limb malformation  1  1/868 (0.12%)  0/868 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis  1  0/868 (0.00%)  1/868 (0.12%) 
Sudden hearing loss  1  0/868 (0.00%)  1/868 (0.12%) 
Vertigo positional  1  0/868 (0.00%)  1/868 (0.12%) 
Endocrine disorders     
Autoimmune thyroiditis  1  0/868 (0.00%)  1/868 (0.12%) 
Basedow's disease  1  2/868 (0.23%)  0/868 (0.00%) 
Goitre  1  0/868 (0.00%)  1/868 (0.12%) 
Hyperthyroidism  1  1/868 (0.12%)  0/868 (0.00%) 
Eye disorders     
Cataract  1  1/868 (0.12%)  0/868 (0.00%) 
Glaucoma  1  1/868 (0.12%)  0/868 (0.00%) 
Retinal ischaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Ulcerative keratitis  1  0/868 (0.00%)  1/868 (0.12%) 
Vision blurred  1  0/868 (0.00%)  1/868 (0.12%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/868 (0.12%)  0/868 (0.00%) 
Abdominal pain  1  0/868 (0.00%)  1/868 (0.12%) 
Colitis  1  0/868 (0.00%)  1/868 (0.12%) 
Colitis ulcerative  1  1/868 (0.12%)  1/868 (0.12%) 
Crohn's disease  1  0/868 (0.00%)  1/868 (0.12%) 
Diarrhoea  1  1/868 (0.12%)  0/868 (0.00%) 
Duodenal ulcer  1  0/868 (0.00%)  1/868 (0.12%) 
Duodenal ulcer perforation  1  1/868 (0.12%)  0/868 (0.00%) 
Duodenitis  1  0/868 (0.00%)  1/868 (0.12%) 
Gastric haemorrhage  1  1/868 (0.12%)  0/868 (0.00%) 
Gastritis  1  2/868 (0.23%)  3/868 (0.35%) 
Gastrointestinal haemorrhage  1  0/868 (0.00%)  1/868 (0.12%) 
Gastrointestinal inflammation  1  1/868 (0.12%)  0/868 (0.00%) 
Gastrointestinal mucosal disorder  1  1/868 (0.12%)  0/868 (0.00%) 
Gastrointestinal necrosis  1  1/868 (0.12%)  0/868 (0.00%) 
Gastrooesophageal reflux disease  1  1/868 (0.12%)  1/868 (0.12%) 
Haemorrhoids  1  0/868 (0.00%)  1/868 (0.12%) 
Inguinal hernia  1  1/868 (0.12%)  3/868 (0.35%) 
Intestinal haemorrhage  1  0/868 (0.00%)  1/868 (0.12%) 
Intestinal obstruction  1  0/868 (0.00%)  1/868 (0.12%) 
Pancreatitis  1  1/868 (0.12%)  0/868 (0.00%) 
Peritonitis  1  1/868 (0.12%)  0/868 (0.00%) 
Small intestinal obstruction  1  1/868 (0.12%)  0/868 (0.00%) 
Subileus  1  1/868 (0.12%)  0/868 (0.00%) 
Umbilical hernia  1  2/868 (0.23%)  0/868 (0.00%) 
Volvulus  1  0/868 (0.00%)  1/868 (0.12%) 
General disorders     
Capsular contracture associated with breast implant  1  1/868 (0.12%)  0/868 (0.00%) 
Chest pain  1  0/868 (0.00%)  1/868 (0.12%) 
Gait disturbance  1  1/868 (0.12%)  0/868 (0.00%) 
Impaired healing  1  1/868 (0.12%)  0/868 (0.00%) 
Non-cardiac chest pain  1  0/868 (0.00%)  3/868 (0.35%) 
Oedema peripheral  1  0/868 (0.00%)  1/868 (0.12%) 
Pyrexia  1  3/868 (0.35%)  1/868 (0.12%) 
Serositis  1  0/868 (0.00%)  1/868 (0.12%) 
Treatment failure  1  0/868 (0.00%)  1/868 (0.12%) 
Hepatobiliary disorders     
Bile duct stone  1  1/868 (0.12%)  1/868 (0.12%) 
Biliary colic  1  0/868 (0.00%)  2/868 (0.23%) 
Cholecystitis  1  3/868 (0.35%)  1/868 (0.12%) 
Cholecystitis acute  1  1/868 (0.12%)  1/868 (0.12%) 
Cholecystitis chronic  1  0/868 (0.00%)  2/868 (0.23%) 
Cholelithiasis  1  2/868 (0.23%)  7/868 (0.81%) 
Chronic hepatitis  1  1/868 (0.12%)  0/868 (0.00%) 
Hepatic failure  1  0/868 (0.00%)  1/868 (0.12%) 
Immune system disorders     
Anaphylactic reaction  1  0/868 (0.00%)  1/868 (0.12%) 
Drug hypersensitivity  1  1/868 (0.12%)  0/868 (0.00%) 
Infections and infestations     
Appendicitis  1  2/868 (0.23%)  4/868 (0.46%) 
Bacterial infection  1  1/868 (0.12%)  0/868 (0.00%) 
Bacteriuria  1  1/868 (0.12%)  0/868 (0.00%) 
Bronchitis  1  1/868 (0.12%)  0/868 (0.00%) 
Bronchopneumonia  1  0/868 (0.00%)  2/868 (0.23%) 
Bronchopulmonary aspergillosis  1  1/868 (0.12%)  0/868 (0.00%) 
Cellulitis  1  2/868 (0.23%)  2/868 (0.23%) 
Chronic sinusitis  1  0/868 (0.00%)  2/868 (0.23%) 
Chronic tonsillitis  1  1/868 (0.12%)  0/868 (0.00%) 
Dengue fever  1  2/868 (0.23%)  0/868 (0.00%) 
Diarrhoea infectious  1  0/868 (0.00%)  1/868 (0.12%) 
Diverticulitis  1  1/868 (0.12%)  0/868 (0.00%) 
Endometritis  1  0/868 (0.00%)  1/868 (0.12%) 
Escherichia infection  1  1/868 (0.12%)  0/868 (0.00%) 
Gastroenteritis  1  2/868 (0.23%)  1/868 (0.12%) 
Gastroenteritis norovirus  1  0/868 (0.00%)  1/868 (0.12%) 
Gastroenteritis rotavirus  1  0/868 (0.00%)  1/868 (0.12%) 
Gastrointestinal bacterial infection  1  0/868 (0.00%)  1/868 (0.12%) 
Genital herpes  1  0/868 (0.00%)  1/868 (0.12%) 
Haematoma infection  1  1/868 (0.12%)  0/868 (0.00%) 
Herpes simplex  1  1/868 (0.12%)  0/868 (0.00%) 
Herpes zoster  1  1/868 (0.12%)  3/868 (0.35%) 
Infected skin ulcer  1  1/868 (0.12%)  0/868 (0.00%) 
Lower respiratory tract infection  1  0/868 (0.00%)  1/868 (0.12%) 
Meningitis viral  1  1/868 (0.12%)  0/868 (0.00%) 
Nasopharyngitis  1  1/868 (0.12%)  0/868 (0.00%) 
Oesophageal candidiasis  1  1/868 (0.12%)  0/868 (0.00%) 
Oral candidiasis  1  0/868 (0.00%)  1/868 (0.12%) 
Osteomyelitis  1  0/868 (0.00%)  1/868 (0.12%) 
Papilloma viral infection  1  1/868 (0.12%)  0/868 (0.00%) 
Pelvic abscess  1  0/868 (0.00%)  1/868 (0.12%) 
Peritonsillar abscess  1  0/868 (0.00%)  1/868 (0.12%) 
Peritonsillitis  1  0/868 (0.00%)  1/868 (0.12%) 
Pneumonia  1  6/868 (0.69%)  1/868 (0.12%) 
Pneumonia bacterial  1  0/868 (0.00%)  1/868 (0.12%) 
Post procedural infection  1  1/868 (0.12%)  0/868 (0.00%) 
Progressive multifocal leukoencephalopathy (PML)  1  0/868 (0.00%)  1/868 (0.12%) 
Pulmonary tuberculoma  1  0/868 (0.00%)  1/868 (0.12%) 
Pyelonephritis acute  1  0/868 (0.00%)  1/868 (0.12%) 
Pyelonephritis chronic  1  1/868 (0.12%)  0/868 (0.00%) 
Pyothorax  1  1/868 (0.12%)  0/868 (0.00%) 
Rectal abscess  1  1/868 (0.12%)  0/868 (0.00%) 
Respiratory tract infection  1  1/868 (0.12%)  0/868 (0.00%) 
Respiratory tract infection viral  1  1/868 (0.12%)  0/868 (0.00%) 
Scrub typhus  1  1/868 (0.12%)  0/868 (0.00%) 
Septic shock  1  1/868 (0.12%)  0/868 (0.00%) 
Sinusitis  1  2/868 (0.23%)  0/868 (0.00%) 
Subcutaneous abscess  1  1/868 (0.12%)  0/868 (0.00%) 
Tooth abscess  1  1/868 (0.12%)  0/868 (0.00%) 
Upper respiratory tract infection  1  1/868 (0.12%)  0/868 (0.00%) 
Urinary tract infection  1  10/868 (1.15%)  4/868 (0.46%) 
Urosepsis  1  0/868 (0.00%)  1/868 (0.12%) 
Vaginal infection  1  1/868 (0.12%)  0/868 (0.00%) 
Vestibular neuronitis  1  0/868 (0.00%)  1/868 (0.12%) 
Viral infection  1  1/868 (0.12%)  1/868 (0.12%) 
Injury, poisoning and procedural complications     
Accident  1  0/868 (0.00%)  1/868 (0.12%) 
Accident at work  1  1/868 (0.12%)  0/868 (0.00%) 
Acetabulum fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Animal bite  1  0/868 (0.00%)  2/868 (0.23%) 
Ankle fracture  1  2/868 (0.23%)  2/868 (0.23%) 
Avulsion fracture  1  1/868 (0.12%)  0/868 (0.00%) 
Brain contusion  1  1/868 (0.12%)  0/868 (0.00%) 
Clavicle fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Comminuted fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Concussion  1  0/868 (0.00%)  1/868 (0.12%) 
Contusion  1  3/868 (0.35%)  1/868 (0.12%) 
Drug toxicity  1  0/868 (0.00%)  1/868 (0.12%) 
Fall  1  13/868 (1.50%)  18/868 (2.07%) 
Femoral neck fracture  1  3/868 (0.35%)  4/868 (0.46%) 
Femur fracture  1  3/868 (0.35%)  0/868 (0.00%) 
Fibula fracture  1  0/868 (0.00%)  3/868 (0.35%) 
Foot fracture  1  2/868 (0.23%)  0/868 (0.00%) 
Hand fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Hip fracture  1  1/868 (0.12%)  1/868 (0.12%) 
Humerus fracture  1  0/868 (0.00%)  4/868 (0.46%) 
Incision site haematoma  1  1/868 (0.12%)  0/868 (0.00%) 
Incisional hernia  1  0/868 (0.00%)  1/868 (0.12%) 
Joint dislocation  1  1/868 (0.12%)  0/868 (0.00%) 
Joint injury  1  0/868 (0.00%)  1/868 (0.12%) 
Joint sprain  1  0/868 (0.00%)  1/868 (0.12%) 
Ligament injury  1  1/868 (0.12%)  0/868 (0.00%) 
Ligament rupture  1  2/868 (0.23%)  0/868 (0.00%) 
Lower limb fracture  1  1/868 (0.12%)  3/868 (0.35%) 
Lumbar vertebral fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Meniscus lesion  1  1/868 (0.12%)  1/868 (0.12%) 
Multiple injuries  1  1/868 (0.12%)  0/868 (0.00%) 
Muscle rupture  1  0/868 (0.00%)  2/868 (0.23%) 
Overdose  1  2/868 (0.23%)  0/868 (0.00%) 
Postoperative hernia  1  1/868 (0.12%)  0/868 (0.00%) 
Pubis fracture  1  1/868 (0.12%)  0/868 (0.00%) 
Radius fracture  1  3/868 (0.35%)  0/868 (0.00%) 
Respiratory fume inhalation disorder  1  0/868 (0.00%)  1/868 (0.12%) 
Rib fracture  1  0/868 (0.00%)  2/868 (0.23%) 
Road traffic accident  1  4/868 (0.46%)  5/868 (0.58%) 
Skeletal injury  1  1/868 (0.12%)  1/868 (0.12%) 
Spinal compression fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Splenic rupture  1  0/868 (0.00%)  1/868 (0.12%) 
Thoracic vertebral fracture  1  0/868 (0.00%)  2/868 (0.23%) 
Tibia fracture  1  1/868 (0.12%)  5/868 (0.58%) 
Ulna fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Wound  1  1/868 (0.12%)  0/868 (0.00%) 
Investigations     
Anticoagulation drug level above therapeutic  1  0/868 (0.00%)  1/868 (0.12%) 
Investigation  1  1/868 (0.12%)  0/868 (0.00%) 
Lymphocyte count decreased  1  0/868 (0.00%)  1/868 (0.12%) 
Metabolism and nutrition disorders     
Dehydration  1  1/868 (0.12%)  1/868 (0.12%) 
Diabetes mellitus  1  1/868 (0.12%)  1/868 (0.12%) 
Hyperglycaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Obesity  1  2/868 (0.23%)  1/868 (0.12%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/868 (0.00%)  1/868 (0.12%) 
Arthritis  1  1/868 (0.12%)  0/868 (0.00%) 
Back pain  1  4/868 (0.46%)  0/868 (0.00%) 
Bursitis  1  1/868 (0.12%)  0/868 (0.00%) 
Chondropathy  1  1/868 (0.12%)  0/868 (0.00%) 
Foot deformity  1  2/868 (0.23%)  2/868 (0.23%) 
Intervertebral disc degeneration  1  0/868 (0.00%)  1/868 (0.12%) 
Intervertebral disc disorder  1  1/868 (0.12%)  0/868 (0.00%) 
Intervertebral disc protrusion  1  5/868 (0.58%)  1/868 (0.12%) 
Musculoskeletal pain  1  0/868 (0.00%)  1/868 (0.12%) 
Myositis  1  1/868 (0.12%)  0/868 (0.00%) 
Osteoarthritis  1  5/868 (0.58%)  4/868 (0.46%) 
Osteonecrosis  1  1/868 (0.12%)  1/868 (0.12%) 
Pathological fracture  1  0/868 (0.00%)  1/868 (0.12%) 
Periarthritis  1  1/868 (0.12%)  3/868 (0.35%) 
Rhabdomyolysis  1  2/868 (0.23%)  0/868 (0.00%) 
Rotator cuff syndrome  1  2/868 (0.23%)  0/868 (0.00%) 
Spinal deformity  1  0/868 (0.00%)  1/868 (0.12%) 
Spondylolisthesis  1  1/868 (0.12%)  0/868 (0.00%) 
Synovitis  1  0/868 (0.00%)  1/868 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenolymphoma  1  0/868 (0.00%)  1/868 (0.12%) 
Anal cancer  1  2/868 (0.23%)  0/868 (0.00%) 
Basal cell carcinoma  1  3/868 (0.35%)  2/868 (0.23%) 
Benign breast neoplasm  1  1/868 (0.12%)  0/868 (0.00%) 
Benign ovarian tumour  1  1/868 (0.12%)  0/868 (0.00%) 
Bowenoid papulosis  1  1/868 (0.12%)  0/868 (0.00%) 
Brain cancer metastatic  1  1/868 (0.12%)  0/868 (0.00%) 
Breast cancer  1  4/868 (0.46%)  8/868 (0.92%) 
Breast cancer in situ  1  1/868 (0.12%)  0/868 (0.00%) 
Breast cancer stage II  1  0/868 (0.00%)  1/868 (0.12%) 
Breast neoplasm  1  0/868 (0.00%)  1/868 (0.12%) 
Carcinoid tumour of the pancreas  1  1/868 (0.12%)  0/868 (0.00%) 
Cervix neoplasm  1  1/868 (0.12%)  0/868 (0.00%) 
Chronic myeloid leukaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Endometrial cancer  1  1/868 (0.12%)  0/868 (0.00%) 
Fibroma  1  0/868 (0.00%)  1/868 (0.12%) 
Glioma  1  1/868 (0.12%)  0/868 (0.00%) 
Haemangioma  1  0/868 (0.00%)  1/868 (0.12%) 
Leiomyoma  1  0/868 (0.00%)  1/868 (0.12%) 
Lung adenocarcinoma stage II  1  1/868 (0.12%)  0/868 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  1/868 (0.12%)  0/868 (0.00%) 
Malignant melanoma  1  2/868 (0.23%)  2/868 (0.23%) 
Meningioma  1  1/868 (0.12%)  0/868 (0.00%) 
Mesothelioma malignant  1  1/868 (0.12%)  0/868 (0.00%) 
Metastatic malignant melanoma  1  1/868 (0.12%)  0/868 (0.00%) 
Metastatic neoplasm  1  1/868 (0.12%)  1/868 (0.12%) 
Pancreatic carcinoma  1  0/868 (0.00%)  1/868 (0.12%) 
Pharyngeal neoplasm benign  1  0/868 (0.00%)  1/868 (0.12%) 
Rectal cancer  1  0/868 (0.00%)  1/868 (0.12%) 
Renal cell carcinoma  1  3/868 (0.35%)  0/868 (0.00%) 
Salivary gland cancer  1  0/868 (0.00%)  1/868 (0.12%) 
Squamous cell carcinoma  1  1/868 (0.12%)  1/868 (0.12%) 
Squamous cell carcinoma of the cervix  1  1/868 (0.12%)  0/868 (0.00%) 
Squamous endometrial carcinoma  1  1/868 (0.12%)  0/868 (0.00%) 
Thyroid cancer  1  2/868 (0.23%)  1/868 (0.12%) 
Transitional cell carcinoma  1  0/868 (0.00%)  1/868 (0.12%) 
Uterine leiomyoma  1  6/868 (0.69%)  3/868 (0.35%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/868 (0.12%)  0/868 (0.00%) 
Cerebral ischaemia  1  0/868 (0.00%)  1/868 (0.12%) 
Cerebrovascular insufficiency  1  1/868 (0.12%)  0/868 (0.00%) 
Cervicobrachial syndrome  1  0/868 (0.00%)  1/868 (0.12%) 
Complex partial seizures  1  0/868 (0.00%)  1/868 (0.12%) 
Convulsion  1  3/868 (0.35%)  2/868 (0.23%) 
Dementia  1  1/868 (0.12%)  0/868 (0.00%) 
Disturbance in attention  1  0/868 (0.00%)  1/868 (0.12%) 
Dysarthria  1  1/868 (0.12%)  0/868 (0.00%) 
Epilepsy  1  1/868 (0.12%)  1/868 (0.12%) 
Headache  1  1/868 (0.12%)  0/868 (0.00%) 
Hemiparesis  1  0/868 (0.00%)  1/868 (0.12%) 
Hypoaesthesia  1  0/868 (0.00%)  2/868 (0.23%) 
Intracranial aneurysm  1  1/868 (0.12%)  0/868 (0.00%) 
Lumbar radiculopathy  1  0/868 (0.00%)  1/868 (0.12%) 
Migraine  1  1/868 (0.12%)  1/868 (0.12%) 
Multiple sclerosis  1  4/868 (0.46%)  2/868 (0.23%) 
Multiple sclerosis relapse  1  116/868 (13.36%)  122/868 (14.06%) 
Muscle spasticity  1  1/868 (0.12%)  0/868 (0.00%) 
Neuralgia  1  1/868 (0.12%)  2/868 (0.23%) 
Optic neuritis  1  0/868 (0.00%)  2/868 (0.23%) 
Paraesthesia  1  0/868 (0.00%)  1/868 (0.12%) 
Paraparesis  1  2/868 (0.23%)  0/868 (0.00%) 
Parkinson's disease  1  1/868 (0.12%)  0/868 (0.00%) 
Quadriparesis  1  1/868 (0.12%)  0/868 (0.00%) 
Radiculitis  1  1/868 (0.12%)  0/868 (0.00%) 
Relapsing-remitting multiple sclerosis  1  2/868 (0.23%)  1/868 (0.12%) 
Sciatica  1  1/868 (0.12%)  1/868 (0.12%) 
Subarachnoid haemorrhage  1  1/868 (0.12%)  0/868 (0.00%) 
Syncope  1  2/868 (0.23%)  1/868 (0.12%) 
Transient global amnesia  1  1/868 (0.12%)  0/868 (0.00%) 
Trigeminal neuralgia  1  1/868 (0.12%)  2/868 (0.23%) 
Uhthoff's phenomenon  1  1/868 (0.12%)  0/868 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed  1  0/868 (0.00%)  1/868 (0.12%) 
Abortion spontaneous  1  1/868 (0.12%)  1/868 (0.12%) 
Complication of pregnancy  1  1/868 (0.12%)  0/868 (0.00%) 
Psychiatric disorders     
Acute psychosis  1  1/868 (0.12%)  1/868 (0.12%) 
Alcoholism  1  1/868 (0.12%)  0/868 (0.00%) 
Anorexia nervosa  1  0/868 (0.00%)  1/868 (0.12%) 
Anxiety disorder  1  1/868 (0.12%)  0/868 (0.00%) 
Burnout syndrome  1  1/868 (0.12%)  0/868 (0.00%) 
Catatonia  1  1/868 (0.12%)  0/868 (0.00%) 
Completed suicide  1  0/868 (0.00%)  2/868 (0.23%) 
Delirium  1  0/868 (0.00%)  1/868 (0.12%) 
Depression  1  0/868 (0.00%)  3/868 (0.35%) 
Drug abuse  1  2/868 (0.23%)  0/868 (0.00%) 
Hallucination  1  1/868 (0.12%)  0/868 (0.00%) 
Major depression  1  0/868 (0.00%)  2/868 (0.23%) 
Mood disorder due to a general medical condition  1  1/868 (0.12%)  0/868 (0.00%) 
Morbid thoughts  1  1/868 (0.12%)  0/868 (0.00%) 
Neurosis  1  1/868 (0.12%)  0/868 (0.00%) 
Psychiatric decompensation  1  0/868 (0.00%)  1/868 (0.12%) 
Psychotic behaviour  1  1/868 (0.12%)  0/868 (0.00%) 
Psychotic disorder  1  0/868 (0.00%)  1/868 (0.12%) 
Psychotic disorder due to a general medical condition  1  0/868 (0.00%)  1/868 (0.12%) 
Stress  1  1/868 (0.12%)  0/868 (0.00%) 
Suicide attempt  1  1/868 (0.12%)  0/868 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/868 (0.12%)  0/868 (0.00%) 
Hydronephrosis  1  1/868 (0.12%)  1/868 (0.12%) 
Nephrolithiasis  1  1/868 (0.12%)  2/868 (0.23%) 
Nephrotic syndrome  1  1/868 (0.12%)  0/868 (0.00%) 
Neurogenic bladder  1  1/868 (0.12%)  0/868 (0.00%) 
Renal failure acute  1  1/868 (0.12%)  0/868 (0.00%) 
Reproductive system and breast disorders     
Breast necrosis  1  1/868 (0.12%)  0/868 (0.00%) 
Cervical dysplasia  1  0/868 (0.00%)  2/868 (0.23%) 
Cystocele  1  1/868 (0.12%)  0/868 (0.00%) 
Dysfunctional uterine bleeding  1  1/868 (0.12%)  0/868 (0.00%) 
Endometrial hyperplasia  1  1/868 (0.12%)  0/868 (0.00%) 
Endometriosis  1  0/868 (0.00%)  3/868 (0.35%) 
Fibrocystic breast disease  1  1/868 (0.12%)  0/868 (0.00%) 
Menorrhagia  1  1/868 (0.12%)  2/868 (0.23%) 
Metrorrhagia  1  1/868 (0.12%)  3/868 (0.35%) 
Ovarian cyst  1  2/868 (0.23%)  1/868 (0.12%) 
Ovarian cyst ruptured  1  0/868 (0.00%)  1/868 (0.12%) 
Pelvic adhesions  1  0/868 (0.00%)  1/868 (0.12%) 
Pelvic pain  1  0/868 (0.00%)  1/868 (0.12%) 
Uterine polyp  1  1/868 (0.12%)  1/868 (0.12%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/868 (0.12%)  0/868 (0.00%) 
Choking  1  0/868 (0.00%)  1/868 (0.12%) 
Chronic obstructive pulmonary disease  1  2/868 (0.23%)  1/868 (0.12%) 
Paranasal cyst  1  0/868 (0.00%)  1/868 (0.12%) 
Pleural effusion  1  1/868 (0.12%)  0/868 (0.00%) 
Pleurisy  1  0/868 (0.00%)  1/868 (0.12%) 
Pneumonia aspiration  1  1/868 (0.12%)  0/868 (0.00%) 
Pulmonary artery thrombosis  1  1/868 (0.12%)  0/868 (0.00%) 
Pulmonary embolism  1  2/868 (0.23%)  1/868 (0.12%) 
Pulmonary sarcoidosis  1  0/868 (0.00%)  1/868 (0.12%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/868 (0.12%)  0/868 (0.00%) 
Dermatitis allergic  1  0/868 (0.00%)  1/868 (0.12%) 
Skin ulcer  1  1/868 (0.12%)  0/868 (0.00%) 
Surgical and medical procedures     
Abdominoplasty  1  1/868 (0.12%)  0/868 (0.00%) 
Aortic valve replacement  1  1/868 (0.12%)  0/868 (0.00%) 
Appendicectomy  1  1/868 (0.12%)  0/868 (0.00%) 
Bladder neck suspension  1  0/868 (0.00%)  1/868 (0.12%) 
Bunion operation  1  0/868 (0.00%)  1/868 (0.12%) 
Caesarean section  1  0/868 (0.00%)  1/868 (0.12%) 
Carpal tunnel decompression  1  0/868 (0.00%)  1/868 (0.12%) 
Cholecystectomy  1  1/868 (0.12%)  0/868 (0.00%) 
Cochlea implant  1  0/868 (0.00%)  1/868 (0.12%) 
Cystocele repair  1  1/868 (0.12%)  0/868 (0.00%) 
Female sterilisation  1  1/868 (0.12%)  1/868 (0.12%) 
Hip arthroplasty  1  1/868 (0.12%)  0/868 (0.00%) 
Hysterectomy  1  0/868 (0.00%)  1/868 (0.12%) 
Knee arthroplasty  1  0/868 (0.00%)  1/868 (0.12%) 
Mammoplasty  1  1/868 (0.12%)  0/868 (0.00%) 
Medical device change  1  0/868 (0.00%)  1/868 (0.12%) 
Medical device removal  1  0/868 (0.00%)  1/868 (0.12%) 
Ovarian cystectomy  1  1/868 (0.12%)  0/868 (0.00%) 
Percutaneous coronary intervention  1  1/868 (0.12%)  0/868 (0.00%) 
Postoperative care  1  0/868 (0.00%)  1/868 (0.12%) 
Surgery  1  0/868 (0.00%)  1/868 (0.12%) 
Thyroidectomy  1  0/868 (0.00%)  1/868 (0.12%) 
Umbilical hernia repair  1  1/868 (0.12%)  0/868 (0.00%) 
Varicose vein operation  1  1/868 (0.12%)  0/868 (0.00%) 
Vascular disorders     
Circulatory collapse  1  1/868 (0.12%)  0/868 (0.00%) 
Deep vein thrombosis  1  1/868 (0.12%)  1/868 (0.12%) 
Hypertension  1  1/868 (0.12%)  0/868 (0.00%) 
Hypertensive crisis  1  0/868 (0.00%)  1/868 (0.12%) 
Venous thrombosis  1  1/868 (0.12%)  0/868 (0.00%) 
Venous thrombosis limb  1  0/868 (0.00%)  1/868 (0.12%) 
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BG00012 240 mg BID BG00012 240 mg TID
Affected / at Risk (%) Affected / at Risk (%)
Total   779/868 (89.75%)   767/868 (88.36%) 
Blood and lymphatic system disorders     
Lymphopenia  1  52/868 (5.99%)  42/868 (4.84%) 
Gastrointestinal disorders     
Abdominal pain  1  50/868 (5.76%)  55/868 (6.34%) 
Abdominal pain upper  1  69/868 (7.95%)  76/868 (8.76%) 
Diarrhoea  1  111/868 (12.79%)  118/868 (13.59%) 
Nausea  1  56/868 (6.45%)  61/868 (7.03%) 
Vomiting  1  42/868 (4.84%)  45/868 (5.18%) 
General disorders     
Fatigue  1  100/868 (11.52%)  102/868 (11.75%) 
Pyrexia  1  47/868 (5.41%)  43/868 (4.95%) 
Infections and infestations     
Bronchitis  1  82/868 (9.45%)  98/868 (11.29%) 
Gastroenteritis  1  52/868 (5.99%)  33/868 (3.80%) 
Herpes zoster  1  47/868 (5.41%)  38/868 (4.38%) 
Influenza  1  87/868 (10.02%)  67/868 (7.72%) 
Nasopharyngitis  1  220/868 (25.35%)  226/868 (26.04%) 
Pharyngitis  1  44/868 (5.07%)  50/868 (5.76%) 
Sinusitis  1  65/868 (7.49%)  63/868 (7.26%) 
Upper respiratory tract infection  1  143/868 (16.47%)  136/868 (15.67%) 
Urinary tract infection  1  196/868 (22.58%)  164/868 (18.89%) 
Injury, poisoning and procedural complications     
Fall  1  60/868 (6.91%)  63/868 (7.26%) 
Investigations     
Alanine aminotransferase increased  1  53/868 (6.11%)  59/868 (6.80%) 
Albumin urine present  1  66/868 (7.60%)  62/868 (7.14%) 
Lymphocyte count decreased  1  56/868 (6.45%)  42/868 (4.84%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  97/868 (11.18%)  115/868 (13.25%) 
Back pain  1  125/868 (14.40%)  125/868 (14.40%) 
Muscle spasms  1  38/868 (4.38%)  49/868 (5.65%) 
Musculoskeletal pain  1  35/868 (4.03%)  49/868 (5.65%) 
Pain in extremity  1  102/868 (11.75%)  92/868 (10.60%) 
Nervous system disorders     
Dizziness  1  60/868 (6.91%)  45/868 (5.18%) 
Headache  1  145/868 (16.71%)  131/868 (15.09%) 
Hypoaesthesia  1  64/868 (7.37%)  49/868 (5.65%) 
Multiple sclerosis relapse  1  324/868 (37.33%)  335/868 (38.59%) 
Paraesthesia  1  57/868 (6.57%)  59/868 (6.80%) 
Psychiatric disorders     
Anxiety  1  31/868 (3.57%)  46/868 (5.30%) 
Depression  1  102/868 (11.75%)  87/868 (10.02%) 
Insomnia  1  52/868 (5.99%)  51/868 (5.88%) 
Renal and urinary disorders     
Haematuria  1  49/868 (5.65%)  61/868 (7.03%) 
Microalbuminuria  1  55/868 (6.34%)  61/868 (7.03%) 
Proteinuria  1  76/868 (8.76%)  81/868 (9.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  54/868 (6.22%)  66/868 (7.60%) 
Skin and subcutaneous tissue disorders     
Erythema  1  47/868 (5.41%)  32/868 (3.69%) 
Pruritus  1  50/868 (5.76%)  38/868 (4.38%) 
Rash  1  45/868 (5.18%)  40/868 (4.61%) 
Vascular disorders     
Flushing  1  170/868 (19.59%)  165/868 (19.01%) 
Hot flush  1  44/868 (5.07%)  53/868 (6.11%) 
Hypertension  1  51/868 (5.88%)  43/868 (4.95%) 
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: US Biogen Clinical Trial Center
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00835770    
Other Study ID Numbers: 109MS303
2008-004753-14 ( EudraCT Number )
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: October 20, 2020
Results First Posted: December 31, 2020
Last Update Posted: December 31, 2020