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NCT Number: NCT07288333

Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurocrine Clinical Site, Kazanlak, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBI-1117570

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35

    Time frame: Day 35

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Event (TEAEs)

    Time frame: Day 1 up to Day 49

Study contacts

Contact information is provided by the study sponsor or research team.

Neurocrine Medical Information Call Center

CONTACT

[email protected]

1-877-641-3461

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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