NCT05182476

Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 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).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo	Oral tablets
DRUG	Luvadaxistat	Oral tablets

Timeline

• Start date: 2021-12-07
• Primary completion: 2024-06-28
• Completion: 2024-10-14
• First posted: 2022-01-10
• Last updated: 2025-07-02

Locations

49 sites across 5 countries: United States, Bulgaria, Czechia, Serbia, Spain

Regulatory

• FDA-regulated drug study