An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT ID: NCT01838668
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2013-03-28
2018-09-04
Brief Summary
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The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region.
The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline.
The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.
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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
Study Groups
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Part I Placebo
Placebo orally twice a day. In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID
Participants will begin the study by taking 1 capsule orally BID for first 7 days and escalate their dosing from day 8 to 2 matching capsules orally BID.
Placebo
Two placebo capsules orally BID
Part I BG00012
BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg BG00012 twice daily (BID) for the first 7 days and 240 mg BG00012 BID thereafter.) In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID
dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID
Part II BG00012
Part II: All participants will receive BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg (1 capsule) BG00012 twice daily (BID) for the first 7 days and 240 mg (2 capsules) BG00012 BID thereafter.
dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID
Interventions
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Placebo
Two placebo capsules orally BID
dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.
• Subjects who participated in and completed Part I per protocol.
Exclusion Criteria
* Pregnant or nursing women.
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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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Neurospol, s.r.o.
Havířov, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Privatni ordinace - neurologie
Hradec Králové, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni poliklinika VFN
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
Teplice, , Czechia
NHO Asahikawa Medical Center
Asahikawa-shi, , Japan
Juntendo University Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Kanazawa Medical University Hospital
Kahoku-gun, , Japan
Saitama Medical Center
Kawagoe-shi, , Japan
Kobe University Hospital
Kobe, , Japan
National Center Hospital, NCNP
Kodaira-shi, , Japan
Kyoto University Hospital
Kyoto, , Japan
NHO Utano Hospital
Kyoto, , Japan
Iwate Medical University Hospital
Morioka, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Irino Clinic, Inc.
Osaka, , Japan
Kindai University Hospital
Osakasayama-shi, , Japan
Tokyotohokeniryokosya Ebara Hospital
Ōta-ku, , Japan
NHO Hokkaido Medical Center
Sapporo, , Japan
CEReS Sapporo Neurology Clinic
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Keio University Hospital
Shinjuku-ku, , Japan
Department of Neurosurgery, Tokyo Women's Medical University
Shinjuku-ku, , Japan
Osaka University Hospital
Suita-shi, , Japan
National Defense Medical College Hospital
Tokorozawa-shi, , Japan
Ehime University Hospital
Toon-shi, , Japan
Tsukuba University Hospital
Tsukuba, , Japan
Yamaguchi University Hospital
Ube-shi, , Japan
Tokyo Womens Medical University Yachiyo Medical Center
Yachiyo-shi, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, , Poland
M.A. - LEK A.M.Maciejowscy SC.
Katowice, , Poland
Nzoz Novo-Med
Katowice, , Poland
Neuro-Care Gabriela Klodowska
Katowice, , Poland
MCD Medical
Krakow, , Poland
Centrum Neurologii K. Selmaj
Lodz, , Poland
Neurologiczny NZOZ Centrum Leczenia SM
Plewiska, , Poland
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
Poznan, , Poland
Miedzyleski Szpital Specjalistyczny
Warsaw, , Poland
Yeungnam University Hospital
Daegu, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Kondo T, Kawachi I, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind APEX study and its open-label extension. Mult Scler J Exp Transl Clin. 2019 Jul 31;5(3):2055217319864974. doi: 10.1177/2055217319864974. eCollection 2019 Jul-Sep.
Saida T, Yamamura T, Kondo T, Yun J, Yang M, Li J, Mahadavan L, Zhu B, Sheikh SI. A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries. BMC Neurol. 2019 Jan 7;19(1):5. doi: 10.1186/s12883-018-1220-3.
Ochi H, Niino M, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. 72-Week Safety and Tolerability of Dimethyl Fumarate in Japanese Patients with Relapsing-remitting Multiple Sclerosis: Analysis of the Randomised, Double Blind, Placebo-Controlled, Phase III APEX Study and its Open-Label Extension. Adv Ther. 2018 Oct;35(10):1598-1611. doi: 10.1007/s12325-018-0788-8. Epub 2018 Sep 11.
Related Links
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EudraCT Tabulated Result
Other Identifiers
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2013-004533-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
109MS305
Identifier Type: -
Identifier Source: org_study_id
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