Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00012 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ludwig Kappos, Prof | Kantonsspital Basel | Principal Investigator |
| Gilmore O'Neill, MB,MRCPI,MMedSc | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital St. Anne | Bmo | 656 91 | Czechia | |||
| Faculty Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30918100 | Derived | 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. | |
| 24131282 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Moscow | 1153682 | Russia |
| Moscow | 123182 | Russia |
| Moscow | 123367 | Russia |
| Moscow | 127018 | Russia |
| Novosibirsk | 630075 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197376 | Russia |
| 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 |
| 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. |
| 18970976 | Derived | 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. |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided