Phase 3
Completed N=1,234
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00420212 ↗Enrolled (actual)
1,234
Serious AEs
17.7%
Results posted
Jun 2014
Primary outcomePrimary: Proportion of Subjects Relapsed — 0.461; 0.270; 0.260 Proportion of subjects,confirmed relapse
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Relapsed |
0.461; 0.270; 0.260 | — |
| SECONDARY Number of New or Newly Enlarging T2 Hyperintense Lesions |
17.0; 2.6; 4.4 | — |
| SECONDARY Number of Gadolinium-enhancing T1-weighted Lesions |
1.8; 0.1; 0.5 | — |
| SECONDARY Number of Subjects With Gadolinium (Gd)-Enhancing Lesions |
103; 142; 130; 16; 8; 10 | — |
| SECONDARY Annualized Relapse Rate |
0.364; 0.172; 0.189 | — |
| SECONDARY Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS) |
0.271; 0.164; 0.177 | — |
Eligibility Criteria
Key Inclusion Criteria
- Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria
- Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00420212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.