Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

Summary

MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.

Timeline

Start

2017-12-15

Primary completion

2020-05-26

Completion

2021-02-15

Outcome

Missed primary endpoint

registry p = 0.043; Mixed Models Analysis; note: The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose. NCT03397134 ↗

release “the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary” minervaneurosciences.com ↗

release “the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary” minervaneurosciences.com ↗

release “The Phase 3 study did not meet its primary endpoint” minervaneurosciences.com ↗

Publications

• Results Davidson M, Saoud J, Staner C, Noel N, Werner S, Luthringer E, Walling D, Weiser M, Harvey PD, Strauss GP, Luthringer R. Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia. Schizophr Bull. 2022 May 7;48(3):609-619. doi: 10.1093/schbul/sbac013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roluperidone	Small molecule	32 mg	—
Subject	Roluperidone	Small molecule	64 mg	—

Indications

No indication recorded.