Phase III study shows Inovelon (rufinamide) well tolerated in Lennox-Gastaut Syndrome- Eisai

Data presented at the American Epilepsy Society show that adjunctive Inovelon (rufinamide), from Eisai, in children aged one to four years with inadequately controlled Lennox-Gastaut Syndrome (LGS) is well tolerated and cognitive development and behaviour is comparable to other adjunctive treatments. Study 303 (NCT01405053), a global, randomised, multicentre, two-year open-label study was conducted to evaluate the cognitive development and behavioural effects, safety, and pharmacokinetics of adjunctive rufinamide treatment in paediatric subjects aged one to four years with inadequately controlled Lennox-Gastaut Syndrome.

The primary endpoint of Study 303 was the change in Child Behaviour Checklist (CBCL) Total Problems Score from baseline to the end of the treatment period (106 weeks), which examines cognitive development and behavioural effects of subjects treated with rufinamide. In Study 303, 25 children received rufinamide and 12 received another approved anti-epileptic drug as add-on to their existing regimen. Using the Child Behaviour Checklist, the cognitive development and behaviour of children who received rufinamide was comparable to that of subjects who received another approvedanti-epileptic drug. The treatment-emergent adverse event (TEAE) incidence was similar between the rufinamide group (88.0%) and the any-other anti-epileptic drug group (83.3%), with most events considered mild or moderate. Vomiting (20%, n=5) and somnolence (16%, n=4) were the only treatment-related TEAEs reported in more than 2 children who received rufinamide.