The pivotal study is a randomized, double-blind, sham stimulation controlled investigation of patients with focal epilepsy, which was previously not achieve seizure control with two or more antiepileptic drugs. By 37.9 % efficacy endpoint was a significantly greater reduction in seizure frequency in the treatment group compared to the sham stimulation group during 3 months blinded show trial. Predetermined based on the statistical method in the clinical protocol ), was the reduction of seizure frequency over the blinded evaluation period 37.9 % in the treatment group compared with a 17.3 – % reduction in the sham stimulation group.
The data , 63 of which are at the American Epilepsy Society Annual Meeting were presented in December 2009, were enrolled from 191 people with drug-resistant focal epilepsy collected at 31 sites in the United States. The results show the RNS system considerably reduces the frequency of seizures disable. ‘The clinical data support that this unique technology can be be an effective method to significantly reduce seizure frequency with a positive safety profile for people with focal epilepsy offer,’said David Roberts, Chief of Neurosurgery said at Dartmouth-Hitchcock Medical Center. ‘Epilepsy is an extremely challenging disease to treat and despite our efforts, there is a large population of people that do not respond well to currently available treatment options. Continue reading