Study Results
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Basic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2004-10-01
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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BG00012
Eligibility Criteria
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Inclusion Criteria
2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
4. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.
Exclusion Criteria
2. History of malignancy.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
5. History of human immunodeficiency virus (HIV).
6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
8. Body weight \>100 kg.
9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
10. Any of the following abnormal blood tests at screening.
11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
12. A medication history that precludes entry into the study.
13. Female subjects who are currently pregnant or breast-feeding.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Ludwig Kappos, Prof
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Basel
Gilmore O'Neill, MB,MRCPI,MMedSc
Role: STUDY_DIRECTOR
Biogen
Locations
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Faculty Hospital St. Anne
Bmo, , Czechia
Faculty Hospital
Hradec Králové, , Czechia
Hospital of Pardubice
Pardupice, , Czechia
Faculty Hospital of Plzen
Pilsen, , Czechia
General Teaching Hospital
Prague, , Czechia
Bochum am St. Josef-Hospital
Bochum, , Germany
Heinrich-Heine-Universitat
Düsseldorf, , Germany
George-August-Universitat Goettigen
Goettigen, , Germany
Uzsoki Hospital
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Petz Aladar County Hospital
Győr, , Hungary
VUMC
Amsterdam, , Netherlands
Academic Hospital Rotterdam
Rotterdam, , Netherlands
SamodzielnyPubliczny Szpital Kliniczny
Bialystok, , Poland
Niesalezny Zespol Opieki Zdrowognej
Bialystok, , Poland
10 Wojskowy Szpital Kliniczny z Poliklinika
Bydgoszcz, , Poland
Wojewodzki Szpital Specjalistczny
Gdansk, , Poland
Slaskiej Akademii Medycznej
Katowice-Ligota, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Panstwowy Szpital Kliniczny
Lodz, , Poland
Samodzielny Publiczny Centralny Szpital
Warsaw, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Veliky Novgorod, , Russia
MS Centrum
Mölndal, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Kantonsspital Basel
Basel, , Switzerland
Hacettepe Unisersitesi
Ankara, , Turkey (Türkiye)
Istanbul University
Istanbul, , Turkey (Türkiye)
University of Instanbul
Istanbul, , Turkey (Türkiye)
Multiple Sclerosis Reseach Clinic
London, , United Kingdom
Institute of Neurology
London, , United Kingdom
Royal Hampshire Hospital
Sheffield, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
Countries
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References
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Mehta 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.
Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22.
Kappos L, Gold R, Miller DH, Macmanus DG, Havrdova E, Limmroth V, Polman CH, Schmierer K, Yousry TA, Yang M, Eraksoy M, Meluzinova E, Rektor I, Dawson KT, Sandrock AW, O'Neill GN; BG-12 Phase IIb Study Investigators. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Oct 25;372(9648):1463-72. doi: 10.1016/S0140-6736(08)61619-0.
Other Identifiers
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C-1900
Identifier Type: -
Identifier Source: org_study_id
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