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Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
Sponsor: Neurocrine Biosciences
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
NBI-1117568
Oral capsules
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