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

NCT03382639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-02-28

Study results available
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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).

Conditions

Interventions

DRUG

Luvadaxistat

TAK-831 tablets.

DRUG

Placebo

Luvadaxistat placebo-matching tablets.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY
  • Neurocrine Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2020-12-29
Completion
2021-01-12
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Italy
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382639 on ClinicalTrials.gov