The main goal of this study is to evaluate how well fingolimod works by seeing how long patients stay on treatment. The study will also compare reasons for discontinuation, adverse events, changes in thinking skills, medication satisfaction and change in brain volume measured by MRI.
Patients who can participate in the study will be in early stages of the disease and have had no treatment or have only been treated with one class of medicines (Interferon beta preparation or glatiramer acetate) for no more than 5 years total exposure. Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study.
The study will last 1 year and will involve 1000 patients at multiple centers in the United States. Patients will be randomly assigned either to fingolimod or to approved disease modifying therapy.
More information can be found
here.