NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Launched by NEUROCRINE BIOSCIENCES · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "NBI-1117568-SCZ3029," is studying a new medication called NBI-1117568 to see if it can help improve the symptoms of schizophrenia in adults who are currently hospitalized. The main goal is to find out if this medication works better than a placebo, which is a treatment that looks like the real medication but has no active ingredients. The trial is looking for adults aged 18 to 65 who have a diagnosis of schizophrenia and are experiencing a significant worsening of their symptoms that requires them to be in the hospital.

To be eligible for this study, participants must be willing to stay in the hospital for the duration of the trial and follow all the rules of the study. They also need to stop taking certain medications before joining the trial. However, people who have certain medical conditions, a recent history of substance use issues, or those who may be at risk of harming themselves or others will not be able to participate. This study has not started recruiting participants yet, but it aims to help find better treatments for those suffering from schizophrenia.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Participant has a primary diagnosis of schizophrenia
• • Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
• • Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
• • Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
• Key Exclusion Criteria:
• • Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
• • Participant has an unstable or poorly controlled medical condition or chronic disease
• • Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
• • Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
• • Participant has a positive alcohol test or drug screen for disallowed substances
• • Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
• • Note: Other protocol-specified inclusion/exclusion criteria may apply.