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Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

NCT00451451 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1417

Last updated 2015-01-26

Study results available
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Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are 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 MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

BG00012

DRUG

Placebo

DRUG

Glatiramer Acetate

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
2007-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Costa Rica
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • India
  • Ireland
  • Israel
  • Latvia
  • Mexico
  • Moldova
  • New Zealand
  • North Macedonia
  • Poland
  • Puerto Rico
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • Ukraine

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 NCT00451451 on ClinicalTrials.gov