NCT07288333 Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
| NCT ID | NCT07288333 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Neurocrine Biosciences |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2027-08 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-02-16 with a primary completion date of 2027-08.
⚠ 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
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
Eligibility Criteria
Key Inclusion Criteria: * 18 to 55 years of age * Primary diagnosis of schizophrenia ≥1 year before screening. * Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization. * Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse. Key Exclusion Criteria: * Considered to be at imminent risk of suicide or injury to self or others. * History of epilepsy, seizures, or convulsions. * Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation. * Currently taking prohibited medications. * Pregnant or lactating. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07288333 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 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 NCT07288333 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07288333 currently recruiting?
Yes, NCT07288333 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07288333 trial being conducted?
This trial is being conducted at Kazanlak, Bulgaria, Pazardzhik, Bulgaria, Targovishte, Bulgaria, Târgu Mureş, Romania and 2 additional locations.
Who is sponsoring the NCT07288333 clinical trial?
NCT07288333 is sponsored by Neurocrine Biosciences. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 120 participants.
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