BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS)
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 58 |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | January 2016 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
The primary objective of the study is to investigate whether treatment with BG00012
(dimethyl fumarate) compared with placebo slows the accumulation of disability not related
to relapses in participants with SPMS; The secondary objective of the study is to assess the
effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and
cognitive function.
(dimethyl fumarate) compared with placebo slows the accumulation of disability not related
to relapses in participants with SPMS; The secondary objective of the study is to assess the
effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and
cognitive function.
Key Inclusion Criteria:
- Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as
relapsing-remitting disease followed by progression of disability independent of or
not explained by relapses.
- Have documented confirmed evidence of disease progression independent of clinical
relapses over the 1 year prior to randomization.
- Have EDSS score of 3.0 to 6.5, inclusive.
- Have an multiple sclerosis (MS) Severity Score of 4 or higher.
Key Exclusion Criteria:
- Have a diagnosis of relapsing remitting multiple sclerosis (RRMS) or primary
progressive MS as defined by the revised McDonald criteria.
- Had a recent clinical relapse (within 3 months) prior to randomization.
- Uncontrolled intercurrent illness including, but not limited to- ongoing or active
infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac
arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled
diabetes; serious or acute psychiatric illness that would limit compliance with study
requirements.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
We found this trial at
8
sites
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