Table of contents

• Overview of the clinical trial
• Who can participate
• Study design and treatment groups
• Phase and study status
• Main endpoint being measured
• What this trial may mean for patients

Overview of the clinical trial

The available trial of NBI-1117570 is an interventional study in adults with schizophrenia who need inpatient hospitalization.^[1] The study is designed to evaluate whether NBI-1117570 can improve behavioral and psychological symptoms of schizophrenia compared with placebo.^[1]

Who can participate

This study is for inpatient adults with schizophrenia, so participants must be adults and must need hospital care during the study.^[1] The source data do not give more detailed inclusion or exclusion criteria, so only this target population can be confirmed.^[1]

Study design and treatment groups

The trial compares NBI-1117570 with placebo, which is a look-alike treatment used for comparison and does not contain the active study medicine.^[1] The intervention list shows oral use, and the study is structured to see whether the study drug performs better than placebo in this hospital-based group.^[1]

The trial is listed as interventional, meaning researchers give a study treatment and then measure the results.^[1] The enrollment is 169 participants, which gives an idea of the planned study size.^[1]

Phase and study status

This study is in Phase 2, a mid-stage trial phase that usually looks at whether a treatment may work while continuing to collect important study data.^[1] The status is Authorised, which means the trial has been approved to proceed according to the source data.^[1]

Main endpoint being measured

The main endpoint is the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score.^[1] PANSS is a standard scale used to measure how severe schizophrenia symptoms are, so this outcome helps researchers see whether symptoms improve from the starting point of the study.^[1]

What this trial may mean for patients

For patients and families, this trial is focused on whether NBI-1117570 can help reduce schizophrenia symptoms in adults who are sick enough to need inpatient care.^[1] Because the study compares the treatment with placebo, it is meant to give a clearer picture of whether any symptom change is linked to the study drug rather than to chance alone.^[1]

The source data do not report results yet, so this article only describes what the trial is studying, who it is for, and how success is being measured.^[1]