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Taking people in RomaniaPhase 3

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
Bucharest, Jassi, and Sanpetru, RomaniaSee the 3 sites
Phase
Phase 3

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 Romania

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
  • Institutul De Psihiatrie Socola IasiJassi, RomaniaTaking people
  • Spitalul Clinic De Psihiatrie Si Neurologie BrasovSanpetru, RomaniaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

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.

ClinicalTrials.gov NCT07114874 · EU CTIS 2025-521216-19-00