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

Last updated: June 25, 2025
Sponsor: Neurocrine Biosciences
Overall Status: Terminated

Phase

2

Condition

Mild Cognitive Impairment

Memory Loss

Mental Disability

Treatment

Placebo

Luvadaxistat

Clinical Study ID

NCT05182476
NBI-1065844-CIAS2023
2021-003834-34
  • Ages 18-50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 07, 2021
Estimated Completion Date:
October 14, 2024

Study 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).

Connect with a study center

  • Neurocrine Clinical Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Neurocrine Clinical Site

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Neurocrine Clinical Site

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Neurocrine Clinical Site

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Neurocrine Clinical Site

    Plzen, 301 00
    Czechia

    Site Not Available

  • Neurocrine Clinical Site

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Neurocrine Clinical Site

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Neurocrine Clinical Site

    Culiacan, 80230
    Mexico

    Site Not Available

  • Neurocrine Clinical Site

    Guadalajara, 44100
    Mexico

    Site Not Available

  • Neurocrine Clinical Site

    Leon, 37000
    Mexico

    Site Not Available

  • Neurocrine Clinical Site

    Monterrey, 64710
    Mexico

    Site Not Available

  • Neurocrine Clinical Site

    San Luis Potosí, 78213
    Mexico

    Site Not Available

  • Neurocrine Clinical Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Gornja Toponica, 18202
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Kovin, 26220
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Nis, 18101
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Novi Kneževac, 23330
    Serbia

    Site Not Available

  • Neurocrine Clinical Site

    Barcelona, 08025
    Spain

    Site Not Available

  • Neurocrine Clinical Site

    Madrid, 28009
    Spain

    Site Not Available

  • Neurocrine Clinical Site

    Sabadell, 08208
    Spain

    Site Not Available

  • Neurocrine Clinical Site

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bentonville, Arkansas 72712
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Anaheim, California 92805
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bellflower, California 90706
    United States

    Site Not Available

  • Neurocrine ClinicalSite

    Bellflower, California 90706
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Culver City, California 90230
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Glendale, California 91206
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Pico Rivera, California 90660
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Riverside, California 92506
    United States

    Site Not Available

  • Neurocrine Clinical Site

    San Diego, California 92103
    United States

    Site Not Available

  • Neurocrine Clinical Site

    San Rafael, California 94901
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Stanford, California 94305
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Torrance, California 90502
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Aventura, Florida 33180
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bonita Springs, Florida 34134
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Homestead, Florida 33032
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Neurocrine Clinical Site

    North Miami, Florida 33161
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Okeechobee, Florida 34972
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Orange City, Florida 32763
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Pensacola, Florida 32502
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Tampa, Florida 33629
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Atlanta, Georgia 30338
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Neurocrine Clinical Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Neurocrine Clinical Site

    New York, New York 10035
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Fairlawn, Ohio 44333
    United States

    Site Not Available

  • Neurocrine Clinical Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Houston, Texas 77030
    United States

    Site Not Available

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