At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Placebo Oral Tablet, Roluperidone 32 mg, and 1 other intervention for Negative Symptoms of Schizophrenia. Completed, enrolled 515 participants across 39 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Placebo administered as a single dose once daily
Roluperidone administered as a single dose once daily
Roluperidone administered as a single dose once daily