HTL0022537

NBI-1117570 is being studied in clinical trials for adults with schizophrenia who need inpatient hospitalization. These trials look at whether it can improve symptoms and how well it works compared with placebo, using standard symptom scales and other trial measures.

Table of Contents

Trial overview

One clinical trial is studying NBI-1117570 in adults with schizophrenia who need inpatient hospitalization.[1] The trial is designed to see whether the study drug can improve behavioral and psychological symptoms of schizophrenia compared with placebo.[1]

This is an interventional study, which means researchers give a study treatment and then measure the results.[1] The trial is in Phase 2, so it is focused on learning more about how well the treatment may work while still collecting study information on safety and effects.[1]

Who can participate

The trial is for inpatient adults with schizophrenia.[1] Inpatient means the person is staying in a hospital setting for treatment, not just coming for a short visit.[1]

The source data does not give more detail about other entry rules, such as exact age limits, symptom levels, or past treatment history.[1]

Study design and treatment groups

The trial compares NBI-1117570 with placebo.[1] A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers compare outcomes in a fair way.[1]

The intervention list shows oral use for NBI-1117570 and a placebo for NBI-1117570.[1] The study data do not provide more detail about the schedule of treatment or how long participants are followed.[1]

What is being measured

The main outcome is the change from baseline in the Positive and Negative Syndrome Scale, or PANSS, total score.[1] Baseline means the starting measurement before treatment begins.[1]

PANSS is a score used to measure how severe schizophrenia symptoms are.[1] In simple terms, the researchers are checking whether symptoms improve after treatment and whether the change is greater than with placebo.[1]

Trial status and size

The trial status is Authorised, which means it has permission to start.[1] The planned enrollment is 169 participants.[1]

Because only one trial is listed in the source data, the current research picture for NBI-1117570 is limited to this Phase 2 study in hospitalized adults with schizophrenia.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521868-35-00 Phase 2 Schizophrenia Authorised 169

Ongoing Clinical Trials on HTL0022537

  • A study to evaluate the effectiveness and safety of NBI-1117570 in adults with schizophrenia who require hospital treatment.

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Poland Romania

Glossary

  • Schizophrenia: A mental health condition that can affect how a person thinks, feels, and behaves.
  • Inpatient: A person who stays in a hospital or clinic overnight or longer for treatment and monitoring.
  • Placebo: A look-alike treatment that does not contain the active study drug. It helps researchers compare results fairly.
  • Phase 2: A mid-stage clinical trial that looks at whether a treatment may work and keeps collecting safety information.
  • Interventional study: A trial where researchers give a study treatment and then measure its effects.
  • PANSS: Short for Positive and Negative Syndrome Scale. It is a scoring tool used to measure the severity of schizophrenia symptoms.
  • Baseline: The starting point before treatment begins. Results are often compared with this first measurement.
  • Efficacy: How well a treatment works in a study.
  • Behavioral and psychological symptoms: Changes in behavior, thinking, mood, or perception that can happen with a mental health condition.
  • Authorized: The trial has received permission to begin.

References

  1. https://clinicaltrials.gov/study/2025-521868-35-00