Phase III PARADIGMS study positive topline results for treatment of children and adolescents (ages 10 to 17) with multiple sclerosis.- Novartis.

Phase III PARADIGMS study positive topline results were announced by Novartis for investigating the safety and efficacy of oral once-daily fingolimod in children and adolescents (ages 10 to 17) with multiple sclerosis (MS). Data show that oral fingolimod resulted in a significant and clinically meaningful reduction in the number of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections. The safety profile of fingolimod was consistent with that seen in other clinical trials, with overall more adverse events reported in the interferon group.

The PARADIGMS study is the first ever randomized, controlled Phase III study of a disease-modifying therapy (DMT) in pediatric MS. Results of the Phase III PARADIGMS study will be presented at the 7th Joint ECTRIMS-ACTRIMS meeting, taking place October 25 - 28, 2017, in Paris, France. Commonly diagnosed during adolescence, pediatric MS is associated with relapses that are more frequent and often more severe than those seen in adults with MS. Relapses negatively affect mobility, balance and cognitive function, and patients with pediatric MS are more likely to accumulate physical disability at an earlier age than those diagnosed as adults. There is currently no treatment indicated for children and adolescents living with MS, based on randomized, controlled, clinical study data. Fingolimod is not currently approved for the treatment of pediatric MS.