An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838668
• Other study ID #: 109MS305
• Secondary ID: 2013-004533-32
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2013
• Est. completion date: September 4, 2018

Study information

• Verified date: October 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 4, 2018
• Est. primary completion date: June 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Placebo
Two placebo capsules orally BID
• dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID

Locations

Country	Name	City	State
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Neurospol, s.r.o.	Havirov
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Privatni ordinace - neurologie	Hradec Kralove
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni poliklinika VFN	Praha 2
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.	Teplice
Japan	NHO Asahikawa Medical Center	Asahikawa-shi
Japan	Juntendo University Hospital	Bunkyo-ku
Japan	Chiba University Hospital	Chiba-shi
Japan	Kyushu University Hospital	Fukuoka-shi
Japan	Kanazawa Medical University Hospital	Kahoku-gun
Japan	Saitama Medical Center	Kawagoe-shi
Japan	Kobe University Hospital	Kobe-shi
Japan	National Center Hospital, NCNP	Kodaira-shi
Japan	Kyoto University Hospital	Kyoto-shi
Japan	NHO Utano Hospital	Kyoto-shi
Japan	Iwate Medical University Hospital	Morioka-shi
Japan	Niigata University Medical & Dental Hospital	Niigata-shi
Japan	Irino Clinic, Inc.	Osaka-shi
Japan	Kindai University Hospital	Osakasayama-shi
Japan	Tokyotohokeniryokosya Ebara Hospital	Ota-ku
Japan	CEReS Sapporo Neurology Clinic	Sapporo-shi
Japan	NHO Hokkaido Medical Center	Sapporo-shi
Japan	Tohoku University Hospital	Sendai-shi
Japan	Department of Neurosurgery, Tokyo Women's Medical University	Shinjuku-ku
Japan	Keio University Hospital	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-shi
Japan	Yamaguchi University Hospital	Ube-shi
Japan	Tokyo Womens Medical University Yachiyo Medical Center	Yachiyo-shi
Japan	Yokohama City University Hospital	Yokohama-shi
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk
Poland	M.A. - LEK A.M.Maciejowscy SC.	Katowice
Poland	Neuro-Care Gabriela Klodowska	Katowice
Poland	Nzoz Novo-Med	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	Warszawa
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Czechia,  Japan,  Korea, Republic of,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.		Part I (Week 24)
Primary	Incidence of treatment-emergent adverse events and serious adverse events		Part II (Up to 4.5 years)
Secondary	Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24		Part I (Week 24)
Secondary	Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline		Part I (Week 24)

External Links

•   EudraCT Tabulated Result