An implantable neural stimulator called Renova™ from Northstar Neuroscience failed a crucial clinical trial evaluating the effectiveness of cortical stimulation and rehab for motor recovery in patients with stroke.
Northstar Neuroscience, Inc. (NASDAQ: NSTR), a medical device company developing therapies for the treatment of neurological diseases and disorders, today announced that its EVEREST(a) pivotal trial evaluating cortical stimulation to improve hand and arm function in stroke survivors did not meet its primary efficacy endpoint.
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.
The company is currently collecting and processing longer-term data through 24 weeks, as well as other secondary endpoints. While our analysis of this data is not complete, based on preliminary review the company does not believe that this analysis, once completed, will demonstrate sufficient evidence of efficacy to support a pre-market approval (PMA) submission to the FDA.