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BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

NCT ID: NCT00835770

Last Updated: 2020-12-31

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1736 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-03

Study Completion Date

2019-11-08

Brief Summary

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The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

Detailed Description

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The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Keywords

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relapsing multiple sclerosis remitting oral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BG00012 plus placebo

In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

BG00012 capsules

Placebo

Intervention Type DRUG

Capsules taken to maintain the blind in the 240 mg BID treatment group.

BG00012

In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

BG00012 capsules

Interventions

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dimethyl fumarate

BG00012 capsules

Intervention Type DRUG

Placebo

Capsules taken to maintain the blind in the 240 mg BID treatment group.

Intervention Type DRUG

Other Intervention Names

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BG00012 Tecfidera DMF

Eligibility Criteria

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Inclusion Criteria

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Exclusion Criteria

* Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
* Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
* Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
Minimum Eligible Age

19 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Loma Linda, California, United States

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Boulder, Colorado, United States

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Fort Collins, Colorado, United States

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North Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Evanston, Illinois, United States

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Fort Wayne, Indiana, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Albany, New York, United States

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Amherst, New York, United States

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Buffalo, New York, United States

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Patchogue, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Bellevue, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Rumford, Rhode Island, United States

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Cordova, Tennessee, United States

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Knoxville, Tennessee, United States

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Houston, Texas, United States

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Newport News, Virginia, United States

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Issaquah, Washington, United States

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Madison, Wisconsin, United States

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Kogarah, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Melbourne, Victoria, Australia

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Box Hill, , Australia

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Chatswood, , Australia

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Fitzroy, , Australia

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Geelong, , Australia

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Sydney, , Australia

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Graz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Belarus, Homyel’ Voblasc’, Belarus

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Belarus’, Vitebsk Oblast, Belarus

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Minsk, , Belarus

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Minsk, , Belarus

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Antwerp, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Damme, , Belgium

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Diepenbeek, , Belgium

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Hechtel-Eksel, , Belgium

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Leuven, , Belgium

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Lodelinsart, , Belgium

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Sint-Truiden, , Belgium

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Tuzla, , Bosnia and Herzegovina

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Lévis, Quebec, Canada

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Edmonton, , Canada

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London, , Canada

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Montreal, , Canada

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Nova Scotia, , Canada

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Ottawa, , Canada

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Regina, , Canada

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Zagreb, , Croatia

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Brno, , Czechia

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Jihlava, , Czechia

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Moravská Ostrava, , Czechia

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Olomouc, , Czechia

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Opava, , Czechia

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Ostrava - Vítkovice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Amiens, , France

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Caen, , France

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Clermont-Ferrand, , France

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Dijon, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nancy, , France

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Nice, , France

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Paris, , France

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Rennes, , France

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Strasbourg, , France

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Berg, Bavaria, Germany

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Steinfurt, Ibbenbueren, Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Erbach im Odenwald, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Marburg, , Germany

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Minden, , Germany

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Munich (München), , Germany

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Münster, , Germany

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Osnabrück, , Germany

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Regensburg, , Germany

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Westerstede, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Ahmedabad, , India

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Bangalore, , India

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Chandigarh, , India

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Hyderabad, , India

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Kolkata, , India

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Kolkata, , India

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Ludhiana, , India

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Ludhiana, , India

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Mangalore, , India

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Mumbai, , India

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New Delhi, , India

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New Delhi, , India

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New Delhi, , India

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Pune, , India

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Dublin, , Ireland

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Ashkelon, , Israel

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Jerusalem, , Israel

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Safed, , Israel

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Roma, , Italy

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Riga, , Latvia

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Guadalajara, , Mexico

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México, , Mexico

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México, , Mexico

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México, , Mexico

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Morelia, , Mexico

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San Luis Potosí City, , Mexico

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Chisinau, , Moldova

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Chisinau, , Moldova

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Breda, , Netherlands

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Geleen, , Netherlands

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Hamilton, , New Zealand

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Skopje, , North Macedonia

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Bialystok, , Poland

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Bialystok, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lódz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Plewiska, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Guaynabo, , Puerto Rico

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Târgu Mures, , Romania

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Timișoara, , Romania

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Cape Town, , South Africa

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Durban, , South Africa

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Barcelona, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Seville, , Spain

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Basel, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Oxford, , United Kingdom

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Sheffield, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Countries

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Guatemala United States Australia Austria Belarus Belgium Bosnia and Herzegovina Bulgaria Canada Croatia Czechia Estonia France Germany Greece India Ireland Israel Italy Latvia Mexico Moldova Netherlands New Zealand North Macedonia Poland Puerto Rico Romania Serbia Slovakia South Africa Spain Switzerland Ukraine United Kingdom

References

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Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.

Reference Type DERIVED
PMID: 37061656 (View on PubMed)

Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.

Reference Type DERIVED
PMID: 32426039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30918100 (View on PubMed)

Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

Reference Type DERIVED
PMID: 26932146 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2008-004753-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109MS303

Identifier Type: -

Identifier Source: org_study_id