BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
ENDORSE
A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
2 other identifiers
interventional
1,736
31 countries
228
Brief Summary
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2009
Longer than P75 for phase_3
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2009
CompletedStudy Start
First participant enrolled
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2019
CompletedResults Posted
Study results publicly available
December 31, 2020
CompletedDecember 31, 2020
December 1, 2020
10.8 years
February 2, 2009
October 20, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (AEs)
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.
Day 1 up to Week 561
Secondary Outcomes (15)
Percentage of Participants Who Had Relapses
Day 1 up to Week 384
Annualized Relapse Rate (ARR)
Day 1 up to Week 384
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
Baseline, Week 384
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Baseline up to Week 288
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Baseline up to Week 288
- +10 more secondary outcomes
Study Arms (2)
BG00012 plus placebo
EXPERIMENTALIn the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.
BG00012
EXPERIMENTALIn the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.
Interventions
BG00012 capsules
Capsules taken to maintain the blind in the 240 mg BID treatment group.
Eligibility Criteria
You may qualify if:
- Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
You may not qualify if:
- Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (246)
Research Site
Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Mesa, Arizona, 85206, United States
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Phoenix, Arizona, 85013, United States
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Loma Linda, California, 92354, United States
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Boulder, Colorado, 80304, United States
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Fort Collins, Colorado, 80528, United States
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North Haven, Connecticut, 06473, United States
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Washington D.C., District of Columbia, 20007, United States
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Maitland, Florida, 32751, United States
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Miami, Florida, 33136, United States
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Naples, Florida, 34102, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30327, United States
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Evanston, Illinois, 60201, United States
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Fort Wayne, Indiana, 46845, United States
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Kansas City, Kansas, 66160, United States
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Wichita, Kansas, 67206, United States
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Shreveport, Louisiana, 71103, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02135, United States
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Boston, Massachusetts, 02215, United States
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Farmington Hills, Michigan, 48334, United States
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Minneapolis, Minnesota, 55414, United States
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Chesterfield, Missouri, 63017, United States
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St Louis, Missouri, 63104, United States
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Albany, New York, 12206, United States
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Amherst, New York, 14226, United States
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Buffalo, New York, 14203, United States
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Patchogue, New York, 11772, United States
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Charlotte, North Carolina, 28204, United States
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Raleigh, North Carolina, 27607, United States
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Bellevue, Ohio, 44811, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43221, United States
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Dayton, Ohio, 45417, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97225, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Rumford, Rhode Island, 02916, United States
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Cordova, Tennessee, 38018, United States
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Knoxville, Tennessee, 37922, United States
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Houston, Texas, 77030, United States
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Newport News, Virginia, 23601, United States
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Issaquah, Washington, 98029, United States
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Madison, Wisconsin, 53792, United States
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Kogarah, New South Wales, 2217, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Melbourne, Victoria, 3084, Australia
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Box Hill, 3128, Australia
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Chatswood, 2067, Australia
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Fitzroy, 3065, Australia
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Geelong, 3220, Australia
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Sydney, 2000, Australia
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Graz, 8036, Austria
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Linz, 4021, Austria
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Vienna, 1090, Austria
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Belarus, Homyel’ Voblasc’, 246029, Belarus
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Belarus’, Vitebsk Oblast, 210023, Belarus
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Minsk, 220114, Belarus
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Minsk, 220116, Belarus
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Antwerp, 2020, Belgium
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Damme, 8340, Belgium
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Diepenbeek, 3590, Belgium
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Hechtel-Eksel, 3940, Belgium
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Leuven, 3000, Belgium
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Lodelinsart, 6042, Belgium
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Sint-Truiden, 3800, Belgium
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Tuzla, 75000, Bosnia and Herzegovina
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Rousse, 7002, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1431, Bulgaria
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Lévis, Quebec, G6V 3Z1, Canada
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Edmonton, T6G 2G3, Canada
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London, N6A 5A5, Canada
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Montreal, H3A 2B4, Canada
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Nova Scotia, B3H 4K4, Canada
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Ottawa, K2G 6E2, Canada
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Regina, S4T 7T1, Canada
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Zagreb, 10000, Croatia
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Brno, 656 91, Czechia
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Jihlava, 586 33, Czechia
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Moravská Ostrava, 702 00, Czechia
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Olomouc, 775 20, Czechia
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Opava, 746 01, Czechia
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Ostrava - Vítkovice, 70300, Czechia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Teplice, 415 01, Czechia
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Pärnu, 80010, Estonia
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Tallinn, 10138, Estonia
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Tallinn, 10617, Estonia
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Tartu, 51014, Estonia
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Amiens, 80054, France
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Caen, 14033, France
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Clermont-Ferrand, 63003, France
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Dijon, 21033, France
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Lille, 59037, France
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Lyon, 69394, France
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Marseille, 13385, France
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Montpellier, 34090, France
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Nancy, 54035, France
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Nice, 06002, France
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Paris, 75019, France
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Rennes, 35033, France
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Strasbourg, 67000, France
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Berg, Bavaria, 82335, Germany
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Steinfurt, Ibbenbueren, 49477, Germany
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Bayreuth, 95445, Germany
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Berlin, 10437, Germany
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Berlin, 10625, Germany
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Berlin, 10961, Germany
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Berlin, 12099, Germany
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Berlin, 12163, Germany
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Berlin, 13347, Germany
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Bochum, 44791, Germany
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Cologne, 50935, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40212, Germany
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Erbach im Odenwald, 64711, Germany
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Erlangen, 91054, Germany
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Essen, 45257, Germany
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Halle, 06120, Germany
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Hamburg, 20099, Germany
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Hamburg, 20246, Germany
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Hamburg, 22083, Germany
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Hanover, 30171, Germany
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Hanover, 30625, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39120, Germany
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Marburg, 35043, Germany
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Minden, 32429, Germany
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Munich (München), 81675, Germany
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Münster, 48149, Germany
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Osnabrück, 49076, Germany
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Regensburg, 93053, Germany
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Westerstede, 26655, Germany
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Athens, 11527, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 57010, Greece
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Ahmedabad, 380006, India
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Bangalore, 560054, India
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Chandigarh, 160012, India
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Hyderabad, 500082, India
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Kolkata, 700054, India
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Kolkata, 700068, India
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Ludhiana, 141001, India
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Ludhiana, 141008, India
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Mangalore, 575002, India
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Mumbai, 400054, India
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New Delhi, 110017, India
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New Delhi, 110029, India
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New Delhi, 110060, India
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Pune, 411001, India
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Pune, 411004, India
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Dublin, DUBLIN 4, Ireland
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Ashkelon, 78278, Israel
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Jerusalem, 9112001, Israel
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Safed, 13100, Israel
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Roma, 00189, Italy
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Riga, LV-1015, Latvia
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Guadalajara, 44610, Mexico
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México, 03310, Mexico
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México, 06700, Mexico
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México, 06720, Mexico
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Morelia, 58000, Mexico
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San Luis Potosí City, 78240, Mexico
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Chisinau, 2001, Moldova
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Chisinau, 2028, Moldova
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Breda, 4818 CK, Netherlands
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Geleen, 6162 BG, Netherlands
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Auckland, 1023, New Zealand
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Christchurch, 8011, New Zealand
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Hamilton, 3204, New Zealand
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Skopje, 1000, North Macedonia
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Bialystok, 15-276, Poland
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Bialystok, 15-402, Poland
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Gdansk, 80-299, Poland
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Gdansk, 80-803, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-594, Poland
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Katowice, 40-752, Poland
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Krakow, 31-505, Poland
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Lódz, 90-153, Poland
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Lublin, 20-954, Poland
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Olsztyn, 10-561, Poland
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Plewiska, 62-064, Poland
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Poznan, 60-355, Poland
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Poznan, 60-539, Poland
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Szczecin, 70-215, Poland
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Szczecin, 71-252, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02-507, Poland
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Warsaw, 02-957, Poland
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Wroclaw, 50-556, Poland
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Guaynabo, 00968, Puerto Rico
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Bucharest, 011464, Romania
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Bucharest, 020125, Romania
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Bucharest, 022104, Romania
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Bucharest, 050098, Romania
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Cluj-Napoca, 400012, Romania
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Târgu Mures, 540136, Romania
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Timișoara, 300736, Romania
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Novi Sad, 21000, Serbia
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Bratislava, 81369, Slovakia
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Bratislava, 82606, Slovakia
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Martin, 03659, Slovakia
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Cape Town, 7925, South Africa
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Durban, 4001, South Africa
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Barcelona, 08035, Spain
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Córdoba, 14011, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Basel, 4031, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61068, Ukraine
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Kharkiv, 61103, Ukraine
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Kyiv, 03110, Ukraine
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Kyiv, 04112, Ukraine
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Lviv, 79010, Ukraine
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Odesa, 65117, Ukraine
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Poltava, 36011, Ukraine
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Vinnytsia, 21005, Ukraine
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Zaporizhzhia, 69600, Ukraine
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London, E1 2EF, United Kingdom
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London, E1 4AT, United Kingdom
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London, SE5 9NT, United Kingdom
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London, W6 8RF, United Kingdom
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Newcastle upon Tyne, NE1 4HH, United Kingdom
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Oxford, OX3 9DU, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (4)
Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
PMID: 37061656DERIVEDGold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
PMID: 32426039DERIVEDMehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
PMID: 30918100DERIVEDGold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
PMID: 26932146DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 4, 2009
Study Start
February 3, 2009
Primary Completion
November 8, 2019
Study Completion
November 8, 2019
Last Updated
December 31, 2020
Results First Posted
December 31, 2020
Record last verified: 2020-12