NCT03359785

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called luvadaxistat. Luvadaxistat is being tested to treat people with schizophrenia. Participants will be randomly assigned to one of the two treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Luvadaxistat 500 milligrams (mg) followed by matching placebo * Matching placebo followed by luvadaxistat 50 mg Participants will receive luvadaxistat 500 mg during the treatment period in which they are assigned to luvadaxistat. Following an interim analysis, there will be a study-wide decision about whether to treat the additional participants with luvadaxistat 500 mg during the active treatment period to or treat them with luvadaxistat 50 mg during this period. After the interim analysis, the participant and study doctor will not be aware of which luvadaxistat dose is being used.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Luvadaxistat	TAK-831 Tablets.
DRUG	Matching Placebo	Matching Placebo Tablets.

Timeline

• Start date: 2018-01-10
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2017-12-02
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study