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Completed

NCT Number: NCT01838668

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

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Two placebo capsules orally BID

dimethyl fumarate

Drug

Two dimethyl fumarate 120mg capsules orally BID

Other names: BG00012, Tecfidera, DMF

Primary outcomes

  1. Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.

    Time frame: Part I (Week 24)

  2. Incidence of treatment-emergent adverse events and serious adverse events

    Time frame: Part II (Up to 4.5 years)

Secondary outcomes

  1. Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24

    Time frame: Part I (Week 24)

  2. Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline

    Time frame: Part I (Week 24)

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Apr 24, 2013
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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