Minerva Neurosciences announced it has completed phase 3 patient randomization in a multicenter trial of roluperidone.
The biopharmaceutical company Minerva Neurosciences announced it has completed phase 3 patient randomization in a multicenter trial of roluperidone for the treatment of negative symptoms of schizophrenia. Negative symptoms can be difficult to treat and even more challenging for family and patients. Patients and relatives are often unaware of the extent of these symptoms and seldom communicate them to the clinician.1 Currently, there are no pharmacological agents approved for the treatment of negative symptoms associated with schizophrenia.
For the trial, 515 patients have been randomized in double-blind, parallel, placebo-controlled groups across clinical sites in Europe and the US. The 12-week study will evaluate the safety and efficacy of roluperidne in both 32 mg and 64 mg doses, measured by the Marder negative symptoms factor score of the Positive and Negative Syndrome Scale.
As reported in a press release, “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 placebo. The core 12-week double-blind 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.”2 Top-line data are expected to be recorded in the second quarter of 2020.
Executive Chairman and Chief Executive Officer of Minerva Neurosciences’s Remy Luthringer, PhD, calls this step a “major milestone” in treating negative symptoms, and the company hopes to focus on addressing unmet needs in treating CNS disorders.
1. Velligan DI, Alphs LD. Negative Symptoms in Schizophrenia: An Update on Identification and Treatment. Psychiatric Times. November 24, 2014. https://www.psychiatrictimes.com/schizophrenia/negative-symptoms-schizophrenia-update-identification-and-treatment. Accessed February 7, 2020.
2. Minerva Neurosciences Announces Completion of Patient Enrollment in Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms in Schizophrenia [press release] February 5, 2020. http://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-completion-patient-enrollment-0. Accessed February 7, 2020.