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NCT Number: NCT07114874

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocrine Clinical Site, Veliko Tarnovo, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

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
  • 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.

Treatment and study plan

NBI-1117568

Drug

NBI-1117568 will be administered per schedule specified in the arm description.

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Neurocrine Medical Information Call Center

CONTACT

[email protected]

877-641-3461

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Aug 11, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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