Tests NBI-1117568 against placebo for schizophrenia in hospitalized adults
Tests an investigational drug against placebo in adults with schizophrenia needing hospital care.
Plain-language title generated from the registry record
Registry title: NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Key facts
- Where
- Budapest, Gyongyos, and Győr, HungarySee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with schizophrenia who have a sudden worsening or relapse of symptoms and need to be in hospital.
- Age
- 18 Years to 65 Years
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia as the main diagnosis, with an acute worsening or relapse of symptoms that needs hospital care.
- Earlier treatment
- People taking prohibited medicines, including antipsychotics, must stop them before the study.
Main reasons for not taking part
- Known allergy to any part of NBI-1117568
- Unstable or poorly controlled medical condition or chronic disease
- Imminent risk of suicide or of harming self or others
- Moderate or severe substance use disorder within 6 months before screening (nicotine and caffeine excepted)
- Positive alcohol test or drug screen for disallowed substances
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07105098, who can take part
Where in Hungary
- Semmelweis UniversityBudapest, HungaryTaking people
- Gyoengyosi Bugat Pal KoerhazGyongyos, HungaryTaking people
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT07105098EU 2025-521215-39-00
- Record updated
- 25 September 2026
- Original description
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.Read full original descriptionShow less
A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Inclusion: 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.
Exclusion: 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; 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 has 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; Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others.