Clinical Trial TitleStudy of an experimental biological drug product compared to placebo administered one time as an infusion in subjects with multiple sclerosis experiencing a relapse.
Clinical Trial Protocol Description:
The purpose of this study is to determine the safety and tolerability of a single dose infusion of an investigational antibody medication to promote remyelination of the central nervous system tissue in patients with MS experiencing an acute relapse. It is expected that up to 40 subjects with MS relapse will participate at study clinics in the United States. Approximately 8 subjects are expected to participate at the Rush MS Center. Subjects will be randomly assigned to receive study drug or an inactive placebo.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a current acute MS relapse which requires high dose steroid treatment (methylprednisolone).
- Are between the ages 18–75.
- Agree to remain in the hospital for 2-3 days to receive study drug.
You will be excluded from the study if any of the following criteria apply to you:
- Are a woman who is pregnant or breast feeding.
- Have HIV, hepatitis B or hepatitis C.
- Have any other uncontrolled or untreated clinically significant medical conditions.
This is a partial list of inclusion and exclusion criteria.