NCT07227818

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	NBI-1117568	Oral capsules
DRUG	Placebo	Oral capsules

Timeline

• Start date: 2025-12-16
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2025-11-13
• Last updated: 2026-04-15

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study