Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00451451 | Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis | PHASE3 | COMPLETED | 1,417 | — | — | Jun 1, 2007 | Aug 1, 2011 | Jan 26, 2015 | 195 | United States, Belarus +26 |
| NCT00420212 | Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis | PHASE3 | COMPLETED | 1,234 | — | — | Jan 1, 2007 | Feb 1, 2011 | Jan 26, 2015 | 159 | United States, Australia +27 |
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\>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
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.
| Arm | Type | Description |
|---|---|---|
| BG00012 240 mg Twice Daily (BID) | EXPERIMENTAL | Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) |
| BG00012 240 mg 3 Times Daily (TID) | EXPERIMENTAL | Participants received two 120 mg BG00012 capsules orally three times daily (TID) |
| Placebo | PLACEBO_COMPARATOR | Participants received two placebo capsules orally three times daily (TID) |
| Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) | ACTIVE_COMPARATOR | Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD) |
| Name | Type | Description |
|---|---|---|
| BG00012 | DRUG | - |
| Placebo | DRUG | - |
| Glatiramer Acetate | DRUG | - |
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization: Key Inclusion Criteria: * Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4 * Must have a baseline EDSS between...