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RECRUITING
NCT07227818
PHASE3

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

Sponsor: Neurocrine Biosciences

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2025-12-16

Completion Date

2029-07

Last Updated

2026-05-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

NBI-1117568

Oral capsules

DRUG

Placebo

Oral capsules

Locations (18)

Neurocrine Clinical Site

Garden Grove, California, United States

Neurocrine Clinical Site

La Habra, California, United States

Neurocrine Clinical Site

Lemon Grove, California, United States

Neurocrine Clinical Site

Oceanside, California, United States

Neurocrine Clinical Site

West Hills, California, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

West Palm Beach, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Flowood, Mississippi, United States

Neurocrine Clinical Site

Cedarhurst, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

Bellevue, Washington, United States