Multiple SclerosisPhase 2NCT00168701
Efficacy and Safety of BG00012 in MS
A Phase 2 study testing BG00012 in people with Multiple Sclerosis, run by Biogen at 42 sites in 10 countries.
Trial summary
Determine the efficacy, safety, and tolerability of BG00012 in MS patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BG00012
- How many people
- 260 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 1 Oct 2004to 31 Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
Russia10 sites
Study site
Moscow, 1153682
Study site
Moscow, 123182
Study site
Moscow, 123367
Study site
Moscow, 127018
Study site
Novosibirsk, 630075
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197376
Study site
Velikiy Novgorod, 603076
Poland8 sites
SamodzielnyPubliczny Szpital Kliniczny
Bialystok, 15-276
Niesalezny Zespol Opieki Zdrowognej
Bialystok, 15-420
10 Wojskowy Szpital Kliniczny z Poliklinika
Bydgoszcz, 85-681
Wojewodzki Szpital Specjalistczny
Gdansk, 80-803
Slaskiej Akademii Medycznej
Katowice-Ligota, 41-741
Szpital Uniwersytecki w Krakowie
Krakow, 31-503
Panstwowy Szpital Kliniczny
Lodz, 90-153
Samodzielny Publiczny Centralny Szpital
Warsaw, 01-097
Czechia5 sites
Faculty Hospital St. Anne
Bmo, 656 91
Faculty Hospital
Hradec Králové, 500 05
Hospital of Pardubice
Pardupice, 532 03
Faculty Hospital of Plzen
Pilsen, 304 60
General Teaching Hospital
Prague, 128 02
United Kingdom4 sites
Multiple Sclerosis Reseach Clinic
London, SE1 9RT
Institute of Neurology
London, WC1N 3BG
Royal Hampshire Hospital
Sheffield, S10 2JF
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 7LN
Germany3 sites
Bochum am St. Josef-Hospital
Bochum, 44791
Heinrich-Heine-Universitat
Düsseldorf, 40225
George-August-Universitat Goettigen
Goettigen, 37073
Hungary3 sites
Uzsoki Hospital
Budapest, 1145
University of Debrecen
Debrecen, 4012
Petz Aladar County Hospital
Győr, 9024
Sweden3 sites
MS Centrum
Mölndal, 431 80
Karolinska University Hospital
Stockholm, 141 86
Karolinska University Hospital
Stockholm, 171 76
Turkey (Türkiye)3 sites
Hacettepe Unisersitesi
Ankara, 6100
Istanbul University
Istanbul, 34303
University of Instanbul
Istanbul, TR-34390
Netherlands2 sites
VUMC
Amsterdam, 1081 HV
Academic Hospital Rotterdam
Rotterdam, 3015 GD
About this study
Official title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
Read the detailed description
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.
- Conditions
- Multiple Sclerosis
- Being tested
- BG00012
- Keywords
- Multiple Sclerosis, MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00012Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
Measured: 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.
Measured: Weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start1 Oct 2004
- Primary completion31 Mar 2006
- Study completion31 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludwig Kappos, Prof, Principal investigator, Kantonsspital BaselGilmore O'Neill, MB,MRCPI,MMedSc, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168701
- Sponsor's protocol ID
- C-1900
- Status last verified
- Aug 2023
- First submitted
- 9 Sep 2005
- Last updated
- 28 Aug 2023
- Results posted
- No
Publications
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.
PubMed 30918100Fox 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.
PubMed 24131282Kappos 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.
PubMed 18970976
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00168701
- Acronym / sponsor ID
- C-1900
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2004 (actual)
- Primary completion
- 31 Mar 2006 (actual)
- Study completion
- 31 Mar 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
Detailed description
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG00012 | Drug | – |
Primary outcome
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
Time frame: Weeks 12, 16, 20, and 24
1 secondary outcome
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.
Time frame: Weeks 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Derived from this study: PubMed 30918100Mehta 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.
- Derived from this study: PubMed 24131282Fox 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.
- Derived from this study: PubMed 18970976Kappos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludwig Kappos, Prof principal investigator
Kantonsspital Basel
Gilmore O'Neill, MB,MRCPI,MMedSc study director
Biogen
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BG00012 in people with Multiple Sclerosis, run by Biogen at 42 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Russia, Poland, Czechia, United Kingdom, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (time frame: Weeks 12, 16, 20, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168701, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.