Mount Sinai School of Medicine is the Clinical Coordinating Center for the first study to assess the effectiveness of combining two FDA approved medications as initial treatment for people with Relapsing Remitting Multiple Sclerosis.
Sponsored by the National Institutes of Health - National Institute of Neurological Disorders and Stroke (NIH-NINDS), the study, known as CombiRx, will determine if the combined use of each treatment reduces relapse rate when compared to either agent alone. Enrollment is currently underway at clinics across the United States and Canada.
According to study chairman, Fred D. Lublin, M.D., Saunders Family Professor of Neurology at Mount Sinai School of Medicine-Corinne Goldsmith Dickinson Center for Multiple Sclerosis, "This is a very important trial because, if effective, combination therapy will allow us to take advantage of these agents that have different and complementary mechanisms of action to slow or halt progression of MS."
An estimated 400,000 Americans suffer from MS, a chronic neurological disease that affects the central nervous system. MS is most commonly diagnosed in young adults. Relapsing-remitting MS, the most common form of new cases of the disease, is characterized by episodes of attacks of neurologic dysfunction, which occur over many years.
Approximately 130,000 MS patients are receiving either FDA-approved interferon beta-1a weekly (Avonex.) or glatiramer acetate daily (Copaxone.) to treat relapsing forms of MS. However, because these agents provide only a partial amelioration of the risk for additional attacks and development of disability, there is a major and continuing need for better therapies. As yet, there is no cure for MS.
CombiRx will determine whether the combination of these treatments is more effective than either treatment alone. This trial is unique among placebo controlled studies, in that none of the participants will receive placebo alone. All participants will receive at least one active, FDA-approved treatment. Specifically, 50% will receive the combined investigational therapy, 25% will receive interferon beta 1-a weekly plus a daily placebo, and 25% will receive glatiramer acetate daily plus a weekly placebo.