Minerva Neurosciences, Inc: Minerva Neurosciences Announces the Results of the Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia Following the Completion of the 40-Week Open-Label Extension
(DB+OLE)
(N=59)
(N=63)
NSFS
About the trial
In the double-blind, placebo-controlled portion of the Phase 3 trial, a total of 515 patients were randomized in a 1:1:1 ratio to 32 mg/day roluperidone, 64 mg/day roluperidone, or placebo for 12 weeks, and 513 patients received study drugs. Of these, 333 patients (65%) entered the 40-week OLE, where patients receiving roluperidone continued to receive the same dose of roluperidone, while patients who received placebo during the double-blind phase were randomized at the beginning of the study to receive either 32 mg or 64 mg during the OLE. A total of 166 patients were treated with the 32 mg dose, and 167 patients with the 64 mg dose. A total of 202 of the 333 patients entering the OLE (61%) completed the 40-wee
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