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news.Vertex Pharmaceuticals has concluded a double-blind, randomized, placebo-controlled Phase 2 study evaluating VX-765 in patient suffering from treatment-resistant epilepsy.
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The study recruited and dosed people who did not benefit from the use of at least two currently available medicines for partial epilepsy.
In the study, the patients received six weeks of treatment with VX-765 or placebo following a six-week baseline period to monitor seizure frequency.
The Phase 2 study’s primary endpoint was the safety and tolerability, and result from the study which demonstrated a similar safety profile for VX-765 as compared to placebo.
However, the secondary endpoint 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.
Vertex Pharma Global Research and Development executive vice president and chief scientific officer Peter Mueller said the results observed in this study provide support for the continued evaluation of VX-765 as part of a larger and longer-duration study in epilepsy planned for later this year."