Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone - Seite 3
Roluperidone Phase 3: ITT and mITT NSFS & PSP total score change from baseline scores and p-values | ||||||
Timepoint |
Intent-to-Treat |
Modified Intent-to-Treat (Excluding patients from 1 site) |
||||
Placebo (N=172) |
64 mg Roluperidone (N=171) |
p-value |
Placebo (N=167) |
64 mg Roluperidone (N=162) |
p-value | |
Primary Endpoint: Marder Negative Symptoms Factor Score | ||||||
Week 2 | -1.6 (0.22) | -1.9 (0.22) | NS | -1.6 (0.22) | -1.9 (0.22) | 0.311 |
Week 4 | -2.0 (0.26) | -2.9 (0.26) | 0.007 | -2.0 (0.26) | -3.0 (0.27) | 0.005 |
Week 8 | -2.9 (0.30) | -3.8 (0.32) | 0.027 | -2.9 (0.31) | -3.9 (0.32) | 0.021 |
Week 12 | -3.5 (0.34) | -4.3 (0.38) | 0.064 | -3.5 (0.35) | -4.5 (0.35) | 0.044 |
Key Secondary Endpoint: Personal and Social Performance Total Score | ||||||
Week 4 | 1.3 (0.56) | 3.2 (0.56) | 0.005 | 1.2 (0.58) | 3.3 (0.59) | 0.004 |
Week 8 | 2.8 (0.66) | 4.8 (0.66) | 0.019 | 2.8 (0.68) | 4.9 (0.68) | 0.014 |
Week 12 | 3.9 (0.73) | 6.1 (0.73) | 0.021 | 3.8 (0.75) | 6.2 (0.77) | 0.017 |
About Minerva Neurosciences:
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Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
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