The Everest trial was designed to determine whether cortical stimulation in conjunction with rehabilitation therapy would lead to greater gains in hand and arm function and activities of daily living than rehabilitation therapy alone. At the four-week follow-up, 30.8% of the patients receiving cortical stimulation achieved the threshold of clinically meaningful improvement for the composite primary efficacy endpoint defined in the study protocol, compared to 29.1% of the patients in the control group. The primary efficacy endpoint required a 20% absolute difference between these two groups and thus the endpoint was not met. Secondary analyses of the components of the primary endpoint also failed to show a statistically meaningful difference between investigational and control subjects.
John Bowers, president and CEO of Northstar Neuroscience, said: “We intend to work with our clinical collaborators to analyze the larger Everest data set with the goal of helping us better understand and evaluate the therapy’s future potential.”