Completion of patient screening in phase III trial of roluperidone to treat negative symptoms in schizophrenia.- Minerva Neurosciences

Minerva Neurosciences, Inc. announced the completion of patient screening in its ongoing Phase III trial with roluperidone to treat negative symptoms in schizophrenia. A total of 857 patients have been screened, and the enrollment of at least 501 patients is expected to be completed before the end of January 2020. Top-line results from the 12-week, double-blind portion of the trial are expected in the second quarter of 2020.This trial is a multicenter, randomized, double-blind, parallel group, placebo-controlled, 12-week study to evaluate the efficacy and safety of 32 milligram (mg) and 64 mg doses of roluperidone as measured by the Positive and Negative Syndrome Scale Marder negative symptoms factor score, the primary endpoint. Secondary endpoints include the Personal and Social Performance Scale and Clinical Global Impression of Severity. Patients are being randomized 1:1:1 to the 32 mg and 64 mg doses of roluperidone and to placebo. The core 12-week phase of the trial is followed by a 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone.