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

June 25, 2025 updated by: Neurocrine Biosciences

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Neurocrine Clinical Site
      • Plovdiv, Bulgaria, 4004
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1113
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1000
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1408
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1510
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1680
        • Neurocrine Clinical Site
  • Czechia
      • Plzen, Czechia, 301 00
        • Neurocrine Clinical Site
      • Praha 10, Czechia, 100 00
        • Neurocrine Clinical Site
      • Praha 6, Czechia, 160 00
        • Neurocrine Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Neurocrine Clinical Site
      • Gornja Toponica, Serbia, 18202
        • Neurocrine Clinical Site
      • Kovin, Serbia, 26220
        • Neurocrine Clinical Site
      • Kragujevac, Serbia, 34000
        • Neurocrine Clinical Site
      • Nis, Serbia, 18101
        • Neurocrine Clinical Site
  • Spain
      • Madrid, Spain, 28009
        • Neurocrine Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Neurocrine Clinical Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Neurocrine Clinical Site
      • Bryant, Arkansas, United States, 72022
        • Neurocrine Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Neurocrine Clinical Site
      • Bellflower, California, United States, 90706
        • Neurocrine Clinical Site
      • Garden Grove, California, United States, 92845
        • Neurocrine Clinical Site
      • Glendale, California, United States, 91206
        • Neurocrine Clinical Site
      • Oceanside, California, United States, 92056
        • Neurocrine Clinical Site
      • Pico Rivera, California, United States, 90660
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92103
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92102
        • Neurocrine Clinical Site
      • San Rafael, California, United States, 94901
        • Neurocrine Clinical Site
      • Stanford, California, United States, 94305
        • Neurocrine Clinical Site
      • Torrance, California, United States, 90502
        • Neurocrine Clinical Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33133
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33176
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33016
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33144
        • Neurocrine Clinical Site
      • Okeechobee, Florida, United States, 34972
        • Neurocrine Clinical Site
      • Pensacola, Florida, United States, 32502
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Neurocrine Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Neurocrine Clinical Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Neurocrine Clinical Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Neurocrine Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Neurocrine Clinical Site
      • Saint Louis, Missouri, United States, 63141
        • Neurocrine Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurocrine Clinical Site
      • New York, New York, United States, 10032
        • Neurocrine Clinical Site
      • New York, New York, United States, 10035
        • Neurocrine Clinical Site
    • Texas
      • DeSoto, Texas, United States, 75115
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

  1. Completed written informed consent.
  2. Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
  3. Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  4. The initial diagnosis of schizophrenia must be ≥1 year before screening.
  5. The participant is currently receiving a stable regimen of psychotropic medications.
  6. Participant has stable symptomatology ≥3 months before the screening visit.
  7. The participant must have an adult informant.
  8. A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive.

Key Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

  1. Pregnant or breastfeeding or plans to become pregnant during the study.
  2. Exhibit more than a minimal level of extrapyramidal signs/symptoms.
  3. Schizophrenia diagnosis occurred before 12 years of age.
  4. Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
  5. Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
  6. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
  7. Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
  8. Positive drug screen for disallowed substances.
  9. Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo daily
Drug: Placebo
Oral tablets
Experimental: Luvadaxistat treatment schedule 1
Luvadaxistat daily
Drug: Luvadaxistat
Oral tablets
Other Names:
  • TAK-831
  • NBI-1065844
Experimental: Luvadaxistat treatment schedule 2
Luvadaxistat daily
Drug: Luvadaxistat
Oral tablets
Other Names:
  • TAK-831
  • NBI-1065844

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
Time Frame: Baseline, Day 98
Baseline, Day 98

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
Time Frame: Baseline, Day 98
Baseline, Day 98
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time Frame: Baseline, Day 98
Baseline, Day 98
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
Time Frame: Baseline, Day 98
Baseline, Day 98

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurocrine Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBI-1065844-CIAS2023
  • 2021-003834-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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