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HIPAA Compliant
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Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
ID07288333

Phase 2a Study of NBI-1117570 Versus Placebo for Treating Adults 18 to 55 Years Old with Schizophrenia Requiring Hospitalization

Led by Neurocrine Biosciences · Updated on 2026-07-22

120

Participants Needed

6

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the drug NBI-1117570 for its effects on behavioral and psychological symptoms in adults with schizophrenia who need inpatient hospitalization. This phase 2a study compares NBI-1117570 to a placebo to assess its efficacy, safety, tolerability, and how the drug is processed in the body. Participants will be randomly assigned to one of three groups a lower-dose NBI-1117570 group, a higher-dose NBI-1117570 group, or a placebo group. The drug and placebo are given orally. The study uses a parallel design with quadruple masking to maintain blinding. The primary treatment period lasts 35 days, after which safety and adverse events are monitored up to 49 days. During the study, participants will have assessments to measure changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also track any treatment-emergent adverse events throughout the treatment and follow-up periods. The trial is sponsored by Neurocrine Biosciences and runs from February 2026 to August 2027.

CONDITIONS

Brief Title

Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

Research Team

N

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