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Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany (TOLERATE)

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ClinicalTrials.gov Identifier: NCT02125604
Recruitment Status : Completed
First Posted : April 29, 2014
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Intervention Drug: dimethyl fumarate
Enrollment 214
Recruitment Details  
Pre-assignment Details A total of 214 participants were screened and enrolled; 3 participants did not receive study drug (1 withdrew consent and 2 did not meet all inclusion/exclusion criteria). A total of 211 participants were included in the safety population.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Period Title: Overall Study
Started 211 [1]
Completed 180
Not Completed 31
Reason Not Completed
Not Specified             4
Investigator Decision             1
Lost to Follow-up             2
Consent Withdrawn             4
Adverse Event             20
[1]
enrolled and received at least 1 dose of study drug
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Baseline Participants 211
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants
40.09  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants
Female
149
  70.6%
Male
62
  29.4%
1.Primary Outcome
Title Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Hide Description The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Overall Treatment Period; n=211 82
Weeks 1-4; n=211 71
Weeks 5-8; n=186 33
Weeks 9-12; n=178 22
2.Primary Outcome
Title Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Hide Description The MAGISS is a questionnaire in which participants reported overall acute gastrointestinal-related events, (especially symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) for each 10 hours after the AM and PM doses of study drug. Participants who rated the intensity of gastrointestinal-related events reported on MAGISS, included the duration of the gastrointestinal-related events and each symptomatic therapy used in the eDiary are presented.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Overall Treatment Period; n=211 83
Weeks 1-4; n=211 72
Weeks 5-8; n=189 34
Weeks 9-12; n=180 26
3.Primary Outcome
Title Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Hide Description The MOGISS is a questionnaire about overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. MOGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall treatment period; n=84 5.94  (2.427)
Week 1-4; n=73 5.75  (2.554)
Week 5-8; n=38 3.53  (2.533)
Week 9-12; n=29 3.1  (2.568)
4.Primary Outcome
Title Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Hide Description The MAGISS is a questionnaire about the overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) following drug administration (acute symptoms). MAGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall treatment period; n=84 5.93  (2.516)
Week 1-4; n=73 5.88  (2.614)
Week 5-8; n=39 3.31  (2.307)
Week 9-12; n=29 3.55  (2.772)
5.Primary Outcome
Title Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Hide Description The percentage of days with GI events as reported on MOGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The symptomatic therapy (ST) categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: percentage of days
Overall treatment period; Any ST (n=84) 38.13  (29.263)
Overall treatment period; ST1 (n=50) 42.08  (27.495)
Overall treatment period; ST2 (n=26) 36.98  (29.754)
Overall treatment period; ST3 (n=20) 39.61  (29.197)
Overall treatment period; ST4 (n=16) 48.15  (30.140)
Overall treatment period; ST5 (n=10) 45.94  (27.147)
Overall treatment period; ST6 (n=8) 44.33  (29.095)
Overall treatment period; ST7 (n=6) 57.52  (21.998)
Overall treatment period; ST8 (n=5) 52.71  (31.829)
Overall treatment period; ST9 (n=3) 32.78  (26.995)
Overall treatment period; ST10 (n=2) 9.20  (2.137)
Week 1-4; Any ST (n=73) 49.58  (29.547)
Week 1-4; ST1 (n=44) 53.92  (27.197)
Week 1-4; ST2 (n=23) 49.53  (32.012)
Week 1-4; ST3 (n=18) 55.31  (29.869)
Week 1-4; ST4 (n=13) 56.63  (25.764)
Week 1-4; ST5 (n=9) 44.42  (32.470)
Week 1-4; ST6 (n=6) 48.48  (35.539)
Week 1-4; ST7 (n=6) 69.78  (24.808)
Week 1-4; ST8 (n=5) 66.43  (31.400)
Week 1-4; ST9 (n=3) 41.41  (34.085)
Week 1-4; ST10 (n=0) NA [1]   (NA)
Week 5-8; Any ST (n=38) 41.55  (38.612)
Week 5-8; ST1 (n=23) 44.04  (41.414)
Week 5-8; ST2 (n=3) 41.67  (52.042)
Week 5-8; ST3 (n=8) 37.45  (37.388)
Week 5-8; ST4 (n=3) 69.14  (44.186)
Week 5-8; ST5 (n=3) 63.75  (31.332)
Week 5-8; ST6 (n=3) 70.42  (25.699)
Week 5-8; ST7 (n=1) 35.71 [2]   (NA)
Week 5-8; ST8 (n=2) 56.88  (40.032)
Week 5-8; ST9 (n=0) NA [1]   (NA)
Week 5-8; ST10 (n=2) 1.79  (2.525)
Week 9-12; Any ST (n=29) 43.27  (42.322)
Week 9-12; ST1 (n=15) 47.66  (43.191)
Week 9-12; ST2 (n=3) 82.72  (29.937)
Week 9-12; ST3 (n=6) 48.85  (50.931)
Week 9-12; ST4 (n=4) 22.12  (20.834)
Week 9-12; ST5 (n=2) 62.50  (53.033)
Week 9-12; ST6 (n=0) NA [1]   (NA)
Week 9-12; ST7 (n=0) NA [1]   (NA)
Week 9-12; ST8 (n=2) 9.26  (13.095)
Week 9-12; ST9 (n=0) NA [1]   (NA)
Week 9-12; ST10 (n=0) NA [1]   (NA)
[1]
No participants used this symptomatic therapy in this time period.
[2]
1 participant used this symptomatic therapy in this time period.
6.Primary Outcome
Title Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Hide Description Percentage of days with GI events as reported on MAGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The ST categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: percentage of days
Overall treatment period; Any ST (n=84) 38.20  (30.516)
Overall treatment period; ST1 (n=50) 41.29  (29.517)
Overall treatment period; ST2 (n=26) 33.67  (27.310)
Overall treatment period; ST3 (n=20) 39.28  (29.165)
Overall treatment period; ST4 (n=16) 49.94  (33.291)
Overall treatment period; ST5 (n=10) 45.65  (27.118)
Overall treatment period; ST6 (n=8) 44.71  (30.374)
Overall treatment period; ST7 (n=6) 55.32  (23.097)
Overall treatment period; ST8 (n=5) 53.42  (31.443)
Overall treatment period; ST9 (n=3) 36.92  (27.800)
Overall treatment period; ST10 (n=2) 10.88  (1.924)
Week 1-4; Any ST (n=73) 51.03  (30.360)
Week 1-4; ST1 (n=44) 54.41  (29.608)
Week 1-4; ST2 (n=23) 47.84  (30.764)
Week 1-4; ST3 (n=18) 56.67  (30.711)
Week 1-4; ST4 (n=13) 58.90  (27.111)
Week 1-4; ST5 (n=9) 53.74  (32.304)
Week 1-4; ST6 (n=6) 46.43  (33.221)
Week 1-4; ST7 (n=6) 67.54  (25.296)
Week 1-4; ST8 (n=5) 69.86  (28.919)
Week 1-4; ST9 (n=3) 47.61  (47.61)
Week 1-4; ST10 (n=0) NA [1]   (NA)
Week 5-8; Any ST (n=38) 40.59  (37.836)
Week 5-8; ST1 (n=23) 41.59  (41.442)
Week 5-8; ST2 (n=3) 47.14  (45.781)
Week 5-8; ST3 (n=8) 38.50  (35.493)
Week 5-8; ST4 (n=3) 62.58  (45.775)
Week 5-8; ST5 (n=3) 56.33  (33.011)
Week 5-8; ST6 (n=3) 71.61  (24.587)
Week 5-8; ST7 (n=1) 35.71 [2]   (NA)
Week 5-8; ST8 (n=2) 62.24  (32.456)
Week 5-8; ST9 (n=0) NA [1]   (NA)
Week 5-8; ST10 (n=2) 10.00  (14.142)
Week 9-12; Any ST (n=29) 41.28  (42.466)
Week 9-12; ST1 (n=15) 44.24  (44.754)
Week 9-12; ST2 (n=3) 76.19  (41.239)
Week 9-12; ST3 (n=6) 51.99  (50.113)
Week 9-12; ST4 (n=4) 15.48  (10.178)
Week 9-12; ST5 (n=2) 63.16  (52.103)
Week 9-12; ST6 (n=0) NA [1]   (NA)
Week 9-12; ST7 (n=0) NA [1]   (NA)
Week 9-12; ST8 (n=2) 13.11  (7.655)
Week 9-12; ST9 (n=0) NA [1]   (NA)
Week 9-12; ST10 (n=0) NA [1]   (NA)
[1]
No participants used this symptomatic therapy in this time period.
[2]
1 participant used this symptomatic therapy in this time period.
7.Secondary Outcome
Title Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12
Hide Description The cumulative percentage of dimethyl fumarate-treated participants with relapsing-remitting multiple sclerosis who required symptomatic therapy up to Week 4, Week 8, and Week 12 were estimated using the Kaplan-Meier method.
Time Frame Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 35.3
Week 8 38.4
Week 12 41.1
8.Secondary Outcome
Title Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Hide Description Symptomatic therapies were classified into 10 main categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (includes Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (non-steroidal anti-inflammatory drug [NSAID]; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). Participants may have taken > 1 symptomatic therapy but were counted only once for the 'All therapies' summary.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
Overall treatment period (OTP): All therapies 84
OTP: Anti-acid production 50
OTP: Anti-bloating/anti-constipation agent 26
OTP: Multi-target/herbal agents 20
OTP: Anti-diarrheal (anti-peristaltic) 16
OTP: Analgesic (NSAID) 10
OTP: Anti-emetic (central) 8
OTP: Anti-emetic (pro-kinetic) 6
OTP: Antacid 5
OTP: Other 3
OTP: Laxative (pro-kinetic) 2
Week 1-4: All therapies 73
Week 1-4: Anti-acid production 44
Week 1-4: Anti-bloating/anti-constipation agent 23
Week 1-4: Multi-target/herbal agents 18
Week 1-4: Anti-diarrheal (anti-peristaltic) 13
Week 1-4: Analgesic (NSAID) 9
Week 1-4: Anti-emetic (central) 6
Week 1-4: Anti-emetic (pro-kinetic) 6
Week 1-4: Antacid 5
Week 1-4: Other 3
Week 5-8: All therapies 38
Week 5-8: Anti-acid production 23
Week 5-8: Multi-target/herbal agents 8
Week 5-8: Analgesic (NSAID) 3
Week 5-8: Anti-bloating/anti-constipation agent 3
Week 5-8: Anti-diarrheal (anti-peristaltic) 3
Week 5-8: Anti-emetic (central) 3
Week 5-8: Antacid 2
Week 5-8: Laxative (pro-kinetic) 2
Week 5-8: Anti-emetic (pro-kinetic) 1
Week 9-12: All therapies 29
Week 9-12: Anti-acid production 15
Week 9-12: Multi-target/herbal agents 6
Week 9-12: Anti-diarrheal (anti-peristaltic) 4
Week 9-12: Anti-bloating.anti-constipation agent 3
Week 9-12: Analgesic (NSAID) 2
Week 9-12: Antacid 2
9.Secondary Outcome
Title Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Hide Description Symptomatic therapies were classified into 10 categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (eg, Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (NSAID; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in 'All therapies'.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: days
OTP: All therapies; n=84 13.15  (19.21)
OTP: Anti-acid production; n=50 16.62  (22.21)
OTP: Anti-bloating/anti-constipation agent; n=26 2.42  (1.81)
OTP: Multi-target/herbal agents; n=20 9.40  (13.95)
OTP: Anti-diarrheal (anti-peristaltic); n=16 3.13  (2.53)
OTP: Analgesic (NSAID); n=10 3.10  (1.73)
OTP: Anti-emetic (central); n=8 3.25  (4.43)
OTP: Anti-emetic (pro-kinetic); n=6 1.83  (0.98)
OTP: Antacid; n=5 3.60  (4.22)
OTP: Other; n=3 1.67  (0.58)
OTP: Laxative (pro-kinetic); n=2 1.00  (0.00)
Week 1-4: All therapies; n=73 6.03  (6.12)
Week 1-4: Anti-acid production; n=44 7.07  (6.73)
Week 1-4: Anti-bloating/anti-constipation; n=23 2.30  (1.89)
Week 1-4: Multi-target/herbal agents; n=18 3.78  (3.06)
Week 1-4: Anti-diarrheal (anti-peristaltic); n=13 2.62  (1.45)
Week 1-4: Analgesic (NSAID); n=9 2.11  (0.93)
Week 1-4: Anti-emetic (central); n=6 3.17  (3.92)
Week 1-4: Anti-emetic (pro-kinetic); n=6 1.67  (0.82)
Week 1-4: Antacid; n=5 1.80  (1.30)
Week 1-4: Other; n=3 1.67  (0.58)
Week 5-8: All therapies; n=38 10.08  (10.56)
Week 5-8: Anti-acid production; n=23 13.00  (11.14)
Week 5-8: Multi-target/herbal agents; n=8 8.50  (10.45)
Week 5-8: Analgesic (NSAID); n=3 2.00  (1.00)
Week 5-8: Anti-bloating/anti-constipation; n=3 1.33  (0.58)
Week 5-8: Anti-diarrheal (anti-peristaltic); n=3 4.00  (3.61)
Week 5-8: Anti-emetic (central); n=3 2.33  (1.15)
Week 5-8: Antacid; n=2 2.50  (2.12)
Week 5-8: Laxative (pro-kinetic); n=2 1.00  (0.00)
Week 5-8: Anti-emetic (prokinetic); n=1 1.00 [1]   (NA)
Week 9-12: All therapies; n=29 9.72  (10.31)
Week 9-12: Anti-acid production; n=15 14.73  (10.91)
Week 9-12: Multi-target/herbal agents; n=6 8.67  (8.57)
Week 9-12: Anti-diarrheal (anti-peristaltic); n=4 1.00  (0.00)
Week 9-12: Anti-bloating/anti-constipation; n=3 2.00  (1.00)
Week 9-12: Analgesic (NSAID); n=2 3.00  (0.00)
Week 9-12: Antacid; n=2 2.00  (1.41)
[1]
One participant only was included.
10.Secondary Outcome
Title Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events
Hide Description Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: percentage of participants
34.6
11.Secondary Outcome
Title Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of dimethyl fumarate.
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description:
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: percentage of participants
6.6
Time Frame Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dimethyl Fumarate
Hide Arm/Group Description Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
All-Cause Mortality
Dimethyl Fumarate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dimethyl Fumarate
Affected / at Risk (%)
Total   5/211 (2.37%) 
Immune system disorders   
Hypersensitivity  1  1/211 (0.47%) 
Investigations   
Alanine aminotransferase increrased  1  1/211 (0.47%) 
Aspartate aminotransferase  1  1/211 (0.47%) 
Gamma-glutamyltransferase  1  1/211 (0.47%) 
Nervous system disorders   
Multiple sclerosis relapse  1  2/211 (0.95%) 
Psychiatric disorders   
Alcohol abuse  1  1/211 (0.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dimethyl Fumarate
Affected / at Risk (%)
Total   129/211 (61.14%) 
General disorders   
Fatigue  1  12/211 (5.69%) 
Infections and infestations   
Nasopharyngitis  1  31/211 (14.69%) 
Nervous system disorders   
Headache  1  14/211 (6.64%) 
Skin and subcutaneous tissue disorders   
Pruritis  1  12/211 (5.69%) 
Vascular disorders   
Flushing  1  105/211 (49.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: Biogen Study Medical Director
Organization: Biogen
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02125604     History of Changes
Other Study ID Numbers: 109MS407
2013-001486-17 ( EudraCT Number )
First Submitted: April 25, 2014
First Posted: April 29, 2014
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017