A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia

Summary

The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).

Timeline

Start

2018-01-04

Primary completion

2020-12-29

Completion

2021-01-12

Outcome

Missed primary endpoint

paper No significant improvements in PANSS NSFS were observed at any dose versus placebo at week 12. PMID 38943928 ↗

registry analysis (superiority test); Placebo vs Luvadaxistat 50 mg; p = 0.426; LS Mean Difference -0.1 (95% CI -1.4 to 1.2); Mixed Models Analysis NCT03382639 ↗

Publications

• Murthy V, Hanson E, DeMartinis N, Asgharnejad M, Dong C, Evans R, Ge T, Dunayevich E, Singh JB, Ratti E, Galderisi S. INTERACT: a randomized phase 2 study of the DAAO inhibitor luvadaxistat in adults with schizophrenia. Schizophr Res. 2024 Aug;270:249-257. doi: 10.1016/j.schres.2024.06.017. Epub 2024 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Luvadaxistat	Small molecule	50 mg	Oral
Subject	Luvadaxistat	Small molecule	125 mg	Oral
Subject	Luvadaxistat	Small molecule	500 mg	Oral

Indications