A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia

Summary

The purpose of this study is to determine whether luvadaxistat is superior to placebo in improving cerebellar function as measured with the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.

Timeline

Start

2018-01-10

Primary completion

2020-12-21

Completion

2020-12-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Luvadaxistat 50 mg vs Placebo (Reference for Luvadaxistat 50 mg); p = 0.2401; LS Mean Difference 0.278; ANOVA NCT03359785 ↗

registry analysis (superiority test); Luvadaxistat 500 mg vs Placebo (Reference for Luvadaxistat 500 mg); p = 0.9053; LS Mean Difference -0.766; ANOVA NCT03359785 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Luvadaxistat	Small molecule	50 mg	Oral
Subject	Luvadaxistat	Small molecule	500 mg	Oral

Indications