The placebo-controlled, double-blind, three-dose study measured drug effect and pattern of response using quantitative electroencephalography (EEG) in healthy volunteers, who all received each dose plus placebo. After each dose, the subject’s brain waves were evaluated over the course of 24 hours, noting quantitative change in each wave and the pattern of the change as an indication of rufinamide activity. The study was conducted in France.
This first trial was completed in less than seven months from design to final dosing and less than a year after the rights to rufinamide in mood disorders were obtained from Novartis in an exclusive licensing agreement.
Stephen Bandak, chief medical officer of Synosia, said: “The data from this study lend support to observations in animal behaviour models and further justify investigation of the effect of rufinamide for mood disorders. The study has also helped us select a dose for our Phase II trial in general anxiety disorder scheduled to start in the US later this year.”