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NCT00420212 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
Phase 3
Development phase
1,234
Enrollment target
20
Study locations

NCT00420212: Completed Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Biogen.

NCT00420212 is a Phase 3 study of Relapsing Remitting Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 1,234 participants, above the 153-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (707% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00420212, a Phase 3 study of Relapsing Remitting Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 3
Development phase
1,234 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.

Interventions

  • DRUG Placebo
  • DRUG BG00012

Study Locations (20)

Massachusetts

  • Research Site - Brighton
  • Research Site - Hopedale
  • Research Site - Lexington
  • Research Site - Springfield
  • Research Site - Worcester

Arizona

  • Research Site - Gilbert
  • Research Site - Phoenix

Illinois

  • Research Site - Evanston
  • Research Site - Palos Heights

Indiana

  • Research Site - Fort Wayne
  • Research Site - Indianapolis

California

  • Research Site - San Francisco

Connecticut

  • Research Site - New Haven

District of Columbia

  • Research Site - Washington D.C.

Florida

  • Research Site - Vero Beach

Trial Details

FieldValue
Enrollment Target 1,234 participants
Start Date 2007-01
Est. Completion 2011-02
Phase Phase 3
Biogen

334 total trials

What the finished NCT00420212 record still lists

NCT00420212 is an interventional study that assigns participants to a tested intervention. Its 1,234 participants enrollment target places it among the larger protocols in the corpus, above the 153-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (707% higher).

The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00420212 names 20 study sites across 13 states, led by Massachusetts, Arizona, Illinois.

Frequently Asked Questions

What is clinical trial NCT00420212 about?

NCT00420212 is a clinical study titled "Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis". 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 wors...

What is the current status of trial NCT00420212?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,234 participants. The study started on 2007-01. Estimated completion is 2011-02.

What conditions does trial NCT00420212 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT00420212?

The interventions under investigation include: Placebo (DRUG), BG00012 (DRUG).

Who is sponsoring clinical trial NCT00420212?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00420212 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Relapsing Remitting Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00420212's enrollment target sits among peer trials

1,234 1st of 25 higher than 25 of 25 other Relapsing Remitting Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Relapsing Remitting Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00420212, the US trial registry maintained by the National Library of Medicine. NCT00420212 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.