BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Public ClinicalTrials.gov record NCT00835770. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00835770
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,736 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 58 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 3, 2009 (Actual)
- Primary completion
- Nov 8, 2019 (Actual)
- Completion
- Nov 8, 2019 (Actual)
- Last update posted
- Dec 31, 2020
2009 – 2019
United States locations
- U.S. sites
- 50
- U.S. states
- 28
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | — |
| Research Site | Huntsville | Alabama | 35801 | — |
| research Site | Mesa | Arizona | 85206 | — |
| Research Site | Phoenix | Arizona | 85013 | — |
| Research Site | Loma Linda | California | 92354 | — |
| Research Site | Boulder | Colorado | 80304 | — |
| Research Site | Fort Collins | Colorado | 80528 | — |
| Research Site | North Haven | Connecticut | 06473 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Maitland | Florida | 32751 | — |
| Research Site | Miami | Florida | 33136 | — |
| Research Site | Naples | Florida | 34102 | — |
| Research Site | Sarasota | Florida | 34239 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Atlanta | Georgia | 30309 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Evanston | Illinois | 60201 | — |
| Research Site | Fort Wayne | Indiana | 46845 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Wichita | Kansas | 67206 | — |
| Research Site | Shreveport | Louisiana | 71103 | — |
| Research Site | Baltimore | Maryland | 21201 | — |
| Research Site | Boston | Massachusetts | 02135 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Farmington Hills | Michigan | 48334 | — |
| Research Site | Minneapolis | Minnesota | 55414 | — |
| Research Site | Chesterfield | Missouri | 63017 | — |
| Research Site | St Louis | Missouri | 63104 | — |
| Research Site | Albany | New York | 12206 | — |
| Research Site | Amherst | New York | 14226 | — |
| Research Site | Buffalo | New York | 14203 | — |
| Research Site | Patchogue | New York | 11772 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Bellevue | Ohio | 44811 | — |
| Research Site | Cleveland | Ohio | 44195 | — |
| Research Site | Columbus | Ohio | 43221 | — |
| Research Site | Dayton | Ohio | 45417 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Philadelphia | Pennsylvania | 19140 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Rumford | Rhode Island | 02916 | — |
| Research Site | Cordova | Tennessee | 38018 | — |
| Research Site | Knoxville | Tennessee | 37922 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Newport News | Virginia | 23601 | — |
| Research Site | Issaquah | Washington | 98029 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 196 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00835770, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 31, 2020 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00835770 live on ClinicalTrials.gov.