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Article: Northstar Neuroscience Receives FDA Approval for a Clinical Study of its Cortical Stimulation System for the Treatment of Major Depressive Disorder.
- Article from:
- Biotech Week
- Article date:
- October 29, 2008
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Northstar Neuroscience, Inc. (NASDAQ: NSTR) announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of a second clinical study of its Renova(TM) Cortical Stimulation System for the treatment of major depressive disorder (MDD). With this approval, the Company expects to begin enrolling patients into its PROSPECT II study this quarter, with preliminary results anticipated during the second half of 2009 (see also Northstar Neuroscience, Inc.).
The PROSPECT II study is a prospective, double-blinded, sham-controlled study designed to build on the positive safety profile and promising efficacy observed in the PROSPECT I feasibility ...