NBI-1117570 for adults hospitalized with schizophrenia

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

This study will see if NBI-1117570 helps reduce behavioral and psychological symptoms in adults with schizophrenia who need hospitalization, compared with a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Neurocrine Biosciences (Industry-sponsored)
• Locations: 2 sites (London and 1 other locations)
• Trial ID: NCT07288333 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional trial testing NBI-1117570 in adults aged 18–55 who are hospitalized for an acute exacerbation of schizophrenia. Eligible participants must have a primary diagnosis of schizophrenia for at least one year and a prior positive response to at least one antipsychotic (other than clozapine); major exclusions include imminent suicide risk, history of seizures, significant cardiovascular disease, pregnancy or breastfeeding, and use of prohibited medications. The investigational drug is compared with placebo during the inpatient stay, with efficacy measured by improvements in behavioral and psychological symptoms. The trial is sponsored by Neurocrine Biosciences and is being run at Neurocrine clinical sites in London and Oxford, UK.

Who should consider this trial

Good fit: Adults 18–55 with a diagnosis of schizophrenia for at least one year who are experiencing an acute relapse requiring hospitalization and who previously responded to at least one antipsychotic (not clozapine) are the intended participants.

Not a fit: Patients who are pregnant or breastfeeding, have a history of seizures, significant cardiovascular disease, are at imminent risk of self-harm or harm to others, or who are taking prohibited medications would be excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, NBI-1117570 could reduce behavioral and psychological symptoms during acute hospitalizations and potentially shorten inpatient stays or improve recovery.

How similar studies have performed: Other antipsychotic and adjunctive agents have shown benefit in acute schizophrenia, but NBI-1117570 appears to be a novel compound with limited published efficacy data to date.

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.

Where this trial is running

London and 1 other locations

• Neurocrine Clinical Site — London, United Kingdom (Recruiting)
• Neurocrine Clinical Site — Oxford, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center

Conditions Schizophrenia; NBI-1117570