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

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: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: Luvadaxistat

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: Interventional
• Enrollment (Actual): 216
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score	Baseline, Day 98

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score	Baseline, Day 98
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	Baseline, Day 98
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score	Baseline, Day 98

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences
• Investigators: Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): October 14, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognitive Impairment; BAC; CIAS; Neurocrine; Luvadaxistat; NBI-1065844; TAK-831; ERUDITE
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Schizophrenia; Cognitive Dysfunction
• Other Study ID 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