Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00451451 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,417
- Enrollment target
NCT00451451: Completed Phase 3 study, sponsored by Biogen.
NCT00451451 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,417 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451451, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,417 participants
- Enrollment target
Study 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.
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 neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\>2.
Interventions
- DRUG Placebo
- DRUG BG00012
- DRUG Glatiramer Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,417 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00451451 record still lists
NCT00451451 is an interventional study that assigns participants to a tested intervention. Its 1,417 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00451451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00451451 about?
NCT00451451 is a clinical study titled "Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis". 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 take...
What is the current status of trial NCT00451451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,417 participants. The study started on 2007-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00451451?
The interventions under investigation include: Placebo (DRUG), BG00012 (DRUG), Glatiramer Acetate (DRUG).
Who is sponsoring clinical trial NCT00451451?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00451451's enrollment target sits among peer trials
1,417 169th of 2000 higher than 1,832 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05890404 · 1,410 participants · NA
SGM Evidenced-Based Mental Healthcare Implementation
- NCT07042451 · 1,410 participants · NA
An Evaluation of the Pink Cloud Application in Post- Treatment Substance Use Disorder Support
- NCT07222566 · 1,410 participants · Phase 3
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- NCT05992935 · 1,405 participants · Phase 1
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia