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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07288333

Enrollment

120

Registered

2025-12-17

Start date

2026-02-16

Completion date

2027-08-01

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, NBI-1117570

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.

Interventions

DRUGNBI-1117570

Oral administration

DRUGPlacebo

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35	Day 35

Secondary

Measure	Time frame
Number of Participants With Treatment-emergent Adverse Event (TEAEs)	Day 1 up to Day 49

Countries

Bulgaria, Romania, United Kingdom

Contacts

CONTACTNeurocrine Medical Information Call Center

medinfo@neurocrine.com1-877-641-3461

STUDY_DIRECTORClinical Development Lead

Neurocrine Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026