The double-blind, randomized, placebo-controlled Phase 2a study of VX-765 enrolled 60 people with treatment-resistant partial onset epilepsy.
The primary endpoint of the study was safety and tolerability, and results from the study showed a similar safety profile for VX-765 as compared to placebo.
Secondary endpoints and additional analyses evaluated the clinical activity of VX-765, and results support the initiation of a larger and longer-duration Phase 2b study of VX-765 in people with treatment-resistant epilepsy.
Vertex expects to begin this trial as early as the fourth quarter of 2011.
In addition to the endpoints specified in the study protocol, a number of additional analyses were conducted to evaluate the clinical activity of VX-765 during the last two weeks of the treatment phase and first two weeks of the follow-up period.