NCT07114874 NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
| NCT ID | NCT07114874 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Neurocrine Biosciences |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2025-07-11 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
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.
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07114874 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07114874 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT07114874 currently recruiting?
Yes, NCT07114874 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07114874 trial being conducted?
This trial is being conducted at Bryant, United States, Little Rock, United States, Cerritos, United States, Chino, United States and 11 additional locations.
Who is sponsoring the NCT07114874 clinical trial?
NCT07114874 is sponsored by Neurocrine Biosciences. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 600 participants.
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