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Looking for participantsPhase2

Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

Sponsor: Neurocrine Biosciences

NCT ID: NCT07288333

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NBI-1117570 (drug), Placebo (drug)
How long the study runs
Study runs about 18 months (dates as stated)
About the drug or intervention
NBI-1117570 — drug: Oral administration · Placebo — drug: Oral administration
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
120
Started
2026-02-16
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for schizophrenia
  • • Phase2 - 120 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with schizophrenia

Where?

  • • London - Neurocrine Clinical Site
  • • Oxford - Neurocrine Clinical Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Schizophrenia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

Biomarkers mentioned

had a positive

Treatment history

Treatments you must have had:

  • ✓ hospitalization

What the study is looking for

  • ✓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...
  • ✓Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the...

Who cannot take part

  • ✗Considered to be at imminent risk of suicide or injury to self or others.
  • ✗History of epilepsy, seizures, or convulsions.
  • ✗Currently taking prohibited medications.
  • ✗Pregnant or lactating.
  • ✗Note: Additional inclusion/exclusion criteria may apply, per protocol.
See the full 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 Is This Study? (2 UK sites)

Neurocrine Clinical Site

London SE5 8AZ, United Kingdom

Recruiting

Neurocrine Clinical Site

Oxford OX3 7JX, United Kingdom

Recruiting

How to Get in Touch

Neurocrine Medical Information Call Center

Sponsor contact

CONTACT

1-877-641-3461 medinfo@neurocrine.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07