🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07227818
Recruiting Phase 3

Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

NCT07227818 · tracked via the Priya Life Science USA tracker
Sponsor
Neurocrine Biosciences
Phase
Phase 3
Started
2025-12-16
Last updated
2026-06-05

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NBI-1117568 →Placebo

NBI-1117568: Oral capsules

Placebo: Oral capsules

Study summary

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. * Participant had the initial diagnosis of schizophrenia ≥1 year before screening. * Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose. Key Exclusion Criteria: * Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \[including dementing illness, myasthenia gravis\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1. * Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease. * Participant has a history of clozapine treatment for treatment-resistant psychosis. * Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening. * Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Neurocrine Clinical Site Garden Grove California Recruiting
Neurocrine Clinical Site La Habra California Recruiting
Neurocrine Clinical Site Lemon Grove California Recruiting
Neurocrine Clinical Site Oceanside California Recruiting
Neurocrine Clinical Site Torrance California Recruiting
Neurocrine Clinical Site West Hills California Recruiting
Neurocrine Clinical Site Hollywood Florida Recruiting
Neurocrine Clinical Site Maitland Florida Recruiting
Neurocrine Clinical Site Miami Florida Recruiting
Neurocrine Clinical Site Miami Florida Recruiting
Neurocrine Clinical Site Tampa Florida Recruiting
Neurocrine Clinical Site West Palm Beach Florida Recruiting
Neurocrine Clinical Site Atlanta Georgia Recruiting
Neurocrine Clinical Site Boston Massachusetts Recruiting
Neurocrine Clinical Site Flowood Mississippi Recruiting
Neurocrine Clinical Site Cedarhurst New York Recruiting
Neurocrine Clinical Site New York New York Recruiting
Neurocrine Clinical Site New York New York Recruiting
Neurocrine Clinical Site The Bronx New York Recruiting
Neurocrine Clinical Site Bellevue Washington Recruiting

More Neurocrine Biosciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07227818 on ClinicalTrials.gov ↗ ← All trials in the USA