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NCT07114874RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
600 (estimated)
First submitted
29 Jul 2025
Start date
11 Jul 2025
Primary completion date
Dec 2031
Lead sponsor
Neurocrine Biosciences
NCT number
NCT07114874
EU CT number
2025-521216-19-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 600
  • From 11 Jul 2025 to the primary completion date, Dec 2031
  • 62 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Other

  • Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
State Psychiatric Hospital - Lovech
Coordinator of this site? Confirm its status
LovechBulgariaRecruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Coordinator of this site? Confirm its status
PlevenBulgariaRecruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
MBAL Dr. Ivan Seliminski Sliven AD
Coordinator of this site? Confirm its status
SlivenBulgariaRecruiting
Center For Mental Health Vratsa EOOD
Coordinator of this site? Confirm its status
VratsaBulgariaRecruiting
Semmelweis University
Coordinator of this site? Confirm its status
BudapestHungaryNot yet recruiting
Clinexpert Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryNot yet recruiting
Gyoengyosi Bugat Pal Koerhaz
Coordinator of this site? Confirm its status
GyongyosHungaryNot yet recruiting
-
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Institutul De Psihiatrie Socola Iasi
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JassiRomaniaRecruiting
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
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SanpetruRomaniaRecruiting
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BelgradeSerbiaRecruiting
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Gornja ToponicaSerbiaRecruiting
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KragujevacSerbiaRecruiting
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AtlantaUnited StatesRecruiting
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AtlantisUnited StatesRecruiting
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AustinUnited StatesRecruiting
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AventuraUnited StatesRecruiting
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BellevueUnited StatesRecruiting
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BostonUnited StatesRecruiting
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BryantUnited StatesRecruiting
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CedarhurstUnited StatesRecruiting
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CerritosUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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ChinoUnited StatesRecruiting
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Culver CityUnited StatesRecruiting
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DecaturUnited StatesRecruiting
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DeSotoUnited StatesRecruiting
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DoralUnited StatesWithdrawn
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FlowoodUnited StatesRecruiting
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GaithersburgUnited StatesRecruiting
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Garden GroveUnited StatesRecruiting
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HollywoodUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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La HabraUnited StatesRecruiting
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Lemon GroveUnited StatesRecruiting
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Little RockUnited StatesRecruiting
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MaitlandUnited StatesRecruiting
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MarltonUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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Miami LakesUnited StatesRecruiting
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New YorkUnited StatesRecruiting
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North CantonUnited StatesRecruiting
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Oak BrookUnited StatesRecruiting
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OceansideUnited StatesRecruiting
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OremUnited StatesRecruiting
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OremUnited StatesRecruiting
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Peachtree CornersUnited StatesRecruiting
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PhiladelphiaUnited StatesRecruiting
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Pico RiveraUnited StatesRecruiting
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RiversideUnited StatesRecruiting
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San DiegoUnited StatesRecruiting
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ShermanUnited StatesRecruiting
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Staten IslandUnited StatesRecruiting
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St LouisUnited StatesRecruiting
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TampaUnited StatesRecruiting
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The BronxUnited StatesRecruiting
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TorranceUnited StatesRecruiting
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WatertownUnited StatesRecruiting
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West HillsUnited StatesCompleted
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West Palm BeachUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.