ST. LOUIS -- Saint Louis University researchers, as a part of a multi-center research study, will enter Phase III clinical testing of teriflunomide, an investigational oral drug for relapsing forms of multiple sclerosis.
|Florian Thomas, M.D.|
Multiple sclerosis (MS) affects around 400,000 people in the United States, with approximately 10,000 new individuals diagnosed each year. MS is a disease in which the body's immune system attacks the protective coating, called myelin, surrounding the nerves within the central nervous system, as well as the nerve fibers themselves. Symptoms can vary, but they generally include fatigue, pain, muscle weakness, numbness, and impaired mobility, balance, cognition and vision.
Though several therapies are approved for the management of MS, many patients continue to have relapses and disability accumulation. Additionally, most MS treatments must be injected into the skin, muscle or veins, making the search for effective oral treatments a top priority.
"Many MS patients have a real aversion to injections," said Florian Thomas, M.D., Ph.D., professor of neurology and psychiatry at Saint Louis University School of Medicine and principal investigator of the study. "A medication in the form of a tablet may make it easier for patients to take it as prescribed and not miss doses."
To qualify for the study, prospective patients must have had one relapse and some kind of disease activity in the last 12 months, been on a stable dose of interferon beta for at least six months and be between the ages of 18 and 56.
Patients will take one of two daily doses of the investigational medication or placebo (contains no medication) while continuing their regular interferon beta treatment. Investigators will evaluate the effectiveness and safety of the drug through seven clinical visits over the course of 48 weeks.
Women who are pregnant, nursing or plan to become pregnant during the study are not eligible for the clinical trial. People with significant liver or bone marrow function are also not qualified.
SLU researchers evaluated teriflunomide in a previous clinical study using magnetic resonance imaging (MRI) of the brain in MS subjects with relapses. The results of that study showed that the average number of active brain lesions per MRI scan during treatment was lower in subjects who received teriflunomide than in subjects who received a placebo.
"As we enter Phase III of clinical testing, we are hopeful that teriflunomide will prove to be a safe, effective and convenient treatment option for MS patients," Thomas said.
People seeking more information about the MS study should contact Susan Eller at 314-977-4867.