Long-term safety study of NBI-1117568 in adults with schizophrenia
Tests NBI-1117568 safety over time in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
Key facts
- Where
- Budapest, Budapest III, and Gyongyos, 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 to test the long-term safety of the drug NBI-1117568.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- A main diagnosis of schizophrenia.
- Earlier treatment
- People taking prohibited medicines, including antipsychotics, must stop them before joining.
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
- 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: NCT07114874, who can take part
Where in Hungary
- Semmelweis UniversityBudapest, HungaryNot yet recruiting
- Clinexpert Kft.Budapest III, HungaryNot yet recruiting
- Gyoengyosi Bugat Pal KoerhazGyongyos, HungaryNot yet recruiting
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
- NCT07114874EU 2025-521216-19-00
- Record updated
- 25 September 2026
- Original description
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.Read full original descriptionShow less
A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Inclusion: Participant has a primary diagnosis of schizophrenia; Participants taking prohibited medications, including antipsychotics, must discontinue before study participation; Participant must reside in a stable housing situation.
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.