Efficacy and Safety of BG00012 in MS
Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
1 other identifier
interventional
260
10 countries
42
Brief Summary
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started Oct 2004
Shorter than P25 for phase_2 multiple-sclerosis
42 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
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2006
CompletedAugust 28, 2023
August 1, 2023
1.5 years
September 9, 2005
August 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
Weeks 12, 16, 20, and 24
Secondary Outcomes (1)
The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48.
Weeks 24 and 48
Interventions
Eligibility Criteria
You may qualify if:
- Must be 18 to 55 years old, inclusive, at the time of informed consent.
- Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- 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.
- Male and female subjects must be willing to take appropriate measures to prevent pregnancy.
You may not qualify if:
- Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]).
- History of malignancy.
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- 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.
- History of human immunodeficiency virus (HIV).
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
- 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.
- Body weight \>100 kg.
- Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- Any of the following abnormal blood tests at screening.
- Any previous treatment with FUMADERM®, FAG-201, or BG00012.
- A medication history that precludes entry into the study.
- Female subjects who are currently pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (42)
Faculty Hospital St. Anne
Bmo, 656 91, Czechia
Faculty Hospital
Hradec Králové, 500 05, Czechia
Hospital of Pardubice
Pardupice, 532 03, Czechia
Faculty Hospital of Plzen
Pilsen, 304 60, Czechia
General Teaching Hospital
Prague, 128 02, Czechia
Bochum am St. Josef-Hospital
Bochum, 44791, Germany
Heinrich-Heine-Universitat
Düsseldorf, 40225, Germany
George-August-Universitat Goettigen
Goettigen, 37073, Germany
Uzsoki Hospital
Budapest, 1145, Hungary
University of Debrecen
Debrecen, 4012, Hungary
Petz Aladar County Hospital
Győr, 9024, Hungary
VUMC
Amsterdam, 1081 HV, Netherlands
Academic Hospital Rotterdam
Rotterdam, 3015 GD, Netherlands
SamodzielnyPubliczny Szpital Kliniczny
Bialystok, 15-276, Poland
Niesalezny Zespol Opieki Zdrowognej
Bialystok, 15-420, Poland
10 Wojskowy Szpital Kliniczny z Poliklinika
Bydgoszcz, 85-681, Poland
Wojewodzki Szpital Specjalistczny
Gdansk, 80-803, Poland
Slaskiej Akademii Medycznej
Katowice-Ligota, 41-741, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-503, Poland
Panstwowy Szpital Kliniczny
Lodz, 90-153, Poland
Samodzielny Publiczny Centralny Szpital
Warsaw, 01-097, Poland
Unknown Facility
Moscow, 1153682, Russia
Unknown Facility
Moscow, 123182, Russia
Unknown Facility
Moscow, 123367, Russia
Unknown Facility
Moscow, 127018, Russia
Unknown Facility
Novosibirsk, 630075, Russia
Unknown Facility
Saint Petersburg, 194044, Russia
Unknown Facility
Saint Petersburg, 194291, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197376, Russia
Unknown Facility
Veliky Novgorod, 603076, Russia
MS Centrum
Mölndal, 431 80, Sweden
Karolinska University Hospital
Stockholm, 141 86, Sweden
Karolinska University Hospital
Stockholm, 171 76, Sweden
Kantonsspital Basel
Basel, CH 4.31, Switzerland
Hacettepe Unisersitesi
Ankara, 6100, Turkey (Türkiye)
Istanbul University
Istanbul, 34303, Turkey (Türkiye)
University of Instanbul
Istanbul, TR-34390, Turkey (Türkiye)
Multiple Sclerosis Reseach Clinic
London, SE1 9RT, United Kingdom
Institute of Neurology
London, WC1N 3BG, United Kingdom
Royal Hampshire Hospital
Sheffield, S10 2JF, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 7LN, United Kingdom
Related Publications (3)
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.
PMID: 30918100DERIVEDFox 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.
PMID: 24131282DERIVEDKappos 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.
PMID: 18970976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludwig Kappos, Prof
Kantonsspital Basel
- STUDY DIRECTOR
Gilmore O'Neill, MB,MRCPI,MMedSc
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
October 1, 2004
Primary Completion
March 31, 2006
Study Completion
March 31, 2006
Last Updated
August 28, 2023
Record last verified: 2023-08