September 29, 2009
Summary: Investigators worldwide are recruiting people at high risk for multiple sclerosis (MS) for a study comparing two doses of oral HMR1726 (teriflunomide), an immune system-modulating agent, and inactive placebo. People at high risk for MS are those who experience a clinically isolated syndrome (CIS, a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and brain magnetic resonance imaging findings suggestive of MS. The study is sponsored by Sanofi-Aventis.
Rationale: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is an agent that may decrease immune system activity in MS. Other studies of teriflunomide in MS are ongoing.
Eligibility and Details: People eligible for participation include individuals 18-55 years of age who experience a clinically isolated syndrome (a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and magnetic resonance imaging findings suggestive of MS.
Participants will be randomly assigned to receive 7 mg teriflunomide, 14 mg or placebo once daily for 108 weeks (about 2 years). The main outcome measure of the study is to determine whether the study drug reduces the time to conversion to clinically definite MS significantly more than placebo. Other measures will be followed including functioning of patients and changes in brain MRI scanning.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit http://www.thetopicstudy.com/.
source: National MS Society
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