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

NCT00835770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1736

Last updated 2020-12-31

Study results available
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Summary

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.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

dimethyl fumarate

BG00012 capsules

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-03
Primary Completion
2019-11-08
Completion
2019-11-08

Countries

  • 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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835770 on ClinicalTrials.gov