An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple SclerosisMultiple Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01838668
- Lead Sponsor
- Biogen
- Brief Summary
This is a multicenter study conducted in 2 parts:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
-
Inclusion Criteria for Part I:
- Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).
- Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.
Key Inclusion Criteria for Part II:
• Subjects who participated in and completed Part I per protocol.
Key
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- Pregnant or nursing women.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I Placebo 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. Part I BG00012 dimethyl fumarate 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 Part II BG00012 dimethyl fumarate 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.
- Primary Outcome Measures
Name Time Method Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. Part I (Week 24) Incidence of treatment-emergent adverse events and serious adverse events Part II (Up to 4.5 years)
- Secondary Outcome Measures
Name Time Method Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24 Part I (Week 24) Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline Part I (Week 24)
Related Research Topics
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Trial Locations
- Locations (54)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Miedzyleski Szpital Specjalistyczny
🇵🇱Warszawa, Poland
Nzoz Novo-Med
🇵🇱Katowice, Poland
Neuro-Care Gabriela Klodowska
🇵🇱Katowice, Poland
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
Irino Clinic, Inc.
🇯🇵Osaka-shi, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Japan
Fakultni poliklinika VFN
🇨🇿Praha 2, Czechia
Nemocnice Jihlava
🇨🇿Jihlava, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
NHO Asahikawa Medical Center
🇯🇵Asahikawa-shi, Japan
Neurospol, s.r.o.
🇨🇿Havirov, Czechia
Privatni ordinace - neurologie
🇨🇿Hradec Kralove, Czechia
Kyushu University Hospital
🇯🇵Fukuoka-shi, Japan
M.A. - LEK A.M.Maciejowscy SC.
🇵🇱Katowice, Poland
MCD Medical
🇵🇱Krakow, Poland
Centrum Neurologii K. Selmaj
🇵🇱Lodz, Poland
Niigata University Medical & Dental Hospital
🇯🇵Niigata-shi, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Keio University Hospital
🇯🇵Shinjuku-ku, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Japan
National Defense Medical College Hospital
🇯🇵Tokorozawa-shi, Japan
Neurologiczny NZOZ Centrum Leczenia SM
🇵🇱Plewiska, Poland
Tsukuba University Hospital
🇯🇵Tsukuba-shi, Japan
Copernicus Podmiot Leczniczy Sp. z o.o.
🇵🇱Gdansk, Poland
Department of Neurosurgery, Tokyo Women's Medical University
🇯🇵Shinjuku-ku, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Japan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Saitama Medical Center
🇯🇵Kawagoe-shi, Japan
National Center Hospital, NCNP
🇯🇵Kodaira-shi, Japan
NHO Hokkaido Medical Center
🇯🇵Sapporo-shi, Japan
CEReS Sapporo Neurology Clinic
🇯🇵Sapporo-shi, Japan
Ehime University Hospital
🇯🇵Toon-shi, Japan
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
🇨🇿Teplice, Czechia
Chiba University Hospital
🇯🇵Chiba-shi, Japan
Kanazawa Medical University Hospital
🇯🇵Kahoku-gun, Japan
Kobe University Hospital
🇯🇵Kobe-shi, Japan
NHO Utano Hospital
🇯🇵Kyoto-shi, Japan
Yamaguchi University Hospital
🇯🇵Ube-shi, Japan
Iwate Medical University Hospital
🇯🇵Morioka-shi, Japan
Osaka University Hospital
🇯🇵Suita-shi, Japan
Tokyotohokeniryokosya Ebara Hospital
🇯🇵Ota-ku, Japan
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Tokyo Womens Medical University Yachiyo Medical Center
🇯🇵Yachiyo-shi, Japan
Yokohama City University Hospital
🇯🇵Yokohama-shi, Japan
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
🇵🇱Poznan, Poland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan