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Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

NCT ID: NCT02472938

Last Updated: 2015-12-28

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-07-31

Brief Summary

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The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Keywords

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Relapsing remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BG00012

120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

dimethyl fumarate 120 mg capsules

Placebo

Placebo capsules orally twice a day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo for BG00012

Interventions

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dimethyl fumarate

dimethyl fumarate 120 mg capsules

Intervention Type DRUG

Placebo

Placebo for BG00012

Intervention Type OTHER

Other Intervention Names

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DMF Tecfidera BG00012

Eligibility Criteria

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Inclusion Criteria

* Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
* Multiple sclerosis (MS) onset within one year before enrolment
* ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
* No previous disease modifying and/or immunosuppressive treatments for MS.
* Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria

* Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
* Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
* Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
* History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
* History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
* History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
* History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
* An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GB Pharma Services & Consulting s.r.l.

INDUSTRY

Sponsor Role collaborator

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

Other Identifiers

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ITA-BGT-14-10682

Identifier Type: OTHER

Identifier Source: secondary_id

BIIT0115

Identifier Type: -

Identifier Source: org_study_id