MedTrace Logo

Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis

NCT00420212 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1234

Last updated 2015-01-26

Study results available
· View outcomes & findings →

Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

BG00012

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Guatemala
  • India
  • Israel
  • Italy
  • Mexico
  • Moldova
  • Netherlands
  • New Zealand
  • North Macedonia
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • Switzerland
  • Ukraine
  • United Kingdom
  • Virgin Islands

Study Locations

More Related Trials

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 NCT00420212 on ClinicalTrials.gov