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Clinical Trial Summary

Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in subjects with schizophrenia.


Clinical Trial Description

A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS). The study will enroll approximately 308 adult subjects with schizophrenia. In addition, the study will evaluate the long-term safety and tolerability of treatment with luvadaxistat. The expected duration of study participation for each subject is approximately 72 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05182476
Study type Interventional
Source Neurocrine Biosciences
Contact Neurocrine Medical Information Call Center
Phone 877-641-3461
Email [email protected]
Status Recruiting
Phase Phase 2
Start date December 7, 2021
Completion date March 2025

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