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

RecruitingPhase 3

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

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Neurocrine Biosciences · Participants: 600 · Started: Jul 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07114874

Locations in the U.S.

ArkansasNeurocrine Clinical Site, Bryant
Neurocrine Clinical Site, Little Rock
CaliforniaNeurocrine Clinical Site, Cerritos
Neurocrine Clinical Site, Chino
Neurocrine Clinical Site, Culver City
Neurocrine Clinical Site, Garden Grove
Neurocrine Clinical Site, La Habra
Neurocrine Clinical Site, Lemon Grove
Neurocrine Clinical Site, Oceanside
Neurocrine Clinical Site, Pico Rivera
Neurocrine Clinical Site, Riverside
Neurocrine Clinical Site, San Diego
Neurocrine Clinical Site, Sherman
Neurocrine Clinical Site, Torrance
FloridaNeurocrine Clinical Site, Atlantis
Neurocrine Clinical Site, Aventura
Neurocrine Clinical Site, Hollywood
Neurocrine Clinical Site, Maitland
Neurocrine Clinical Site, Miami
Neurocrine Clinical Site, Miami Lakes
Neurocrine Clinical Site, Tampa
Neurocrine Clinical Site, West Palm Beach
GeorgiaNeurocrine Clinical Site, Atlanta
Neurocrine Clinical Site, Atlanta
Neurocrine Clinical Site, Decatur
Neurocrine Clinical Sites, Peachtree Corners
IllinoisNeurocrine Clinical Site, Chicago
Neurocrine Clinical Site, Oak Brook
MarylandNeurocrine Clinical Site, Gaithersburg
MassachusettsNeurocrine Clinical Site, Boston
Neurocrine Clinical Site, Watertown
MississippiNeurocrine Clinical Site, Flowood
MissouriNeurocrine Clinical Site, St Louis
New JerseyNeurocrine Clinical Site, Marlton
New YorkNeurocrine Clinical Site, Cedarhurst
Neurocrine Clinical Site, New York
Neurocrine Clinical Site, New York
Neurocrine Clincial Site, Staten Island
Neurocrine Clinical Sites, The Bronx
OhioNeurocrine Clinical Sites, North Canton
PennsylvaniaNeurocrine Clinical Site, Philadelphia
TexasNeurocrine Clinical Site, Austin
Neurocrine Clinical Site, DeSoto
Neurocrine Clinical Site, Houston
UtahNeurocrine Clinical Site, Orem
Neurocrine Clinical Sites, Orem
WashingtonNeurocrine Clinical Site, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.