Apr. 14, 2010 Mount Sinai researchers took part in a Phase II study of teriflunomide, an investigational oral medication for relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. The study analyzed teriflunomide added to ongoing treatment with glatiramer acetate, a currently prescribed medication, and determined that teriflunomide was safe and effective as part of combination therapy.
Researchers evaluated 123 patients with RRMS over 24 weeks. Patients were given teriflunomide in doses of seven mg/day or 14 mg/day, while a control group received a placebo. Study participants were evaluated through physical examination, laboratory data, electrocardiogram, pancreatic ultrasound, and MRI.
Teriflunomide had a positive safety profile, with only seven treatment emergent adverse events (TEAE) leading to treatment discontinuation. MRI studies revealed that teriflunomide also proved to be effective at reducing the size and volume of lesions on the brain.
"While our study was designed to evaluate the safety of teriflunomide, we determined that in addition to being safe it was also effective in reducing the size and number of lesions in people with RRMS," said Aaron Miller, MD, Professor of Neurology, and Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine. "Further data are required to evaluate efficacy of this combination therapy, but the results are promising."
The study "Oral Teriflunomide or Placebo Added to Glatiramer Acetate for 6 Months in Patients with Relapsing Multiple Sclerosis: Safety and Efficacy Results" was presented April 14, 2010 at the American Academy of Neurology (AAN) Annual Meeting in Toronto, Canada.
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