NCT05545111

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	NBI-1117568	Active treatment with orally administered NBI-1117568
DRUG	Placebo	Placebo matching NBI-1117568

Timeline

• Start date: 2022-10-04
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2022-09-19
• Last updated: 2025-07-11

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study