NCT03397134

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

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: Minerva Neurosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Negative Symptoms of Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	Placebo administered as a single dose once daily
DRUG	Roluperidone 32 mg	Roluperidone administered as a single dose once daily
DRUG	Roluperidone 64 mg	Roluperidone administered as a single dose once daily

Timeline

• Start date: 2017-12-15
• Primary completion: 2020-05-26
• Completion: 2021-02-15
• First posted: 2018-01-11
• Last updated: 2023-04-28
• Results posted: 2023-04-28

Locations

39 sites across 4 countries: United States, Bulgaria, Poland, Ukraine

Regulatory

• FDA-regulated drug study