RecruitingPhase 2NCT07288333

Evaluation of NBI-1117570 in Inpatient Adults 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

Sponsor

Neurocrine Biosciences

Enrollment

120 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

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.

Exclusion Criteria5

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.

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