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

NCT05182476 | Terminated Phase 2 FDA Drug

• 2 other identifiers: NBI-1065844-CIAS20232021-003834-34
• Study Type: interventional
• Target: 216
• Locations: 5 countries
• Sites: 49

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Cognitive Impairment; Luvadaxistat; NBI-1065844; TAK-831; CIAS; BAC; ERUDITE; Neurocrine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score

  Baseline, Day 98

Secondary Outcomes (3)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo daily

Drug: Placebo

Luvadaxistat treatment schedule 1

EXPERIMENTAL

Luvadaxistat daily

Drug: Luvadaxistat

Luvadaxistat treatment schedule 2

EXPERIMENTAL

Luvadaxistat daily

Drug: Luvadaxistat

Interventions

Placebo DRUG

Oral tablets

Placebo

Luvadaxistat DRUG

Oral tablets

Also known as: NBI-1065844, TAK-831

Luvadaxistat treatment schedule 1; Luvadaxistat treatment schedule 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completed written informed consent.
• Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
• Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• The initial diagnosis of schizophrenia must be ≥1 year before screening.
• The participant is currently receiving a stable regimen of psychotropic medications.
• Participant has stable symptomatology ≥3 months before the screening visit.
• The participant must have an adult informant.
• 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.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following criteria:
• Pregnant or breastfeeding or plans to become pregnant during the study.
• Exhibit more than a minimal level of extrapyramidal signs/symptoms.
• Schizophrenia diagnosis occurred before 12 years of age.
• Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
• Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
• 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.
• Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
• Positive drug screen for disallowed substances.
• Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (49)

Neurocrine Clinical Site

Phoenix, Arizona, 85012, United States

Location

Neurocrine Clinical Site

Bentonville, Arkansas, 72712, United States

Location

Neurocrine Clinical Site

Bryant, Arkansas, 72022, United States

Location

Neurocrine Clinical Site

Anaheim, California, 92805, United States

Location

Neurocrine Clinical Site

Bellflower, California, 90706, United States

Location

Neurocrine Clinical Site

Garden Grove, California, 92845, United States

Location

Neurocrine Clinical Site

Glendale, California, 91206, United States

Location

Neurocrine Clinical Site

Oceanside, California, 92056, United States

Location

Neurocrine Clinical Site

Pico Rivera, California, 90660, United States

Location

Neurocrine Clinical Site

San Diego, California, 92102, United States

Location

Neurocrine Clinical Site

San Diego, California, 92103, United States

Location

Neurocrine Clinical Site

San Rafael, California, 94901, United States

Location

Neurocrine Clinical Site

Stanford, California, 94305, United States

Location

Neurocrine Clinical Site

Torrance, California, 90502, United States

Location

Neurocrine Clinical Site

Aventura, Florida, 33180, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33016, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33133, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33144, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33176, United States

Location

Neurocrine Clinical Site

Okeechobee, Florida, 34972, United States

Location

Neurocrine Clinical Site

Pensacola, Florida, 32502, United States

Location

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

Location

Neurocrine Clinical Site

Atlanta, Georgia, 30338, United States

Location

Neurocrine Clinical Site

Chicago, Illinois, 60640, United States

Location

Neurocrine Clinical Site

Ann Arbor, Michigan, 48105, United States

Location

Neurocrine Clinical Site

Flowood, Mississippi, 39232, United States

Location

Neurocrine Clinical Site

St Louis, Missouri, 63128, United States

Location

Neurocrine Clinical Site

St Louis, Missouri, 63141, United States

Location

Neurocrine Clinical Site

Cedarhurst, New York, 11516, United States

Location

Neurocrine Clinical Site

New York, New York, 10032, United States

Location

Neurocrine Clinical Site

New York, New York, 10035, United States

Location

Neurocrine Clinical Site

DeSoto, Texas, 75115, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77030, United States

Location

Neurocrine Clinical Site

Pleven, 5800, Bulgaria

Location

Neurocrine Clinical Site

Plovdiv, 4004, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1000, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1113, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1408, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1510, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1680, Bulgaria

Location

Neurocrine Clinical Site

Pilsen, 301 00, Czechia

Location

Neurocrine Clinical Site

Prague, 100 00, Czechia

Location

Neurocrine Clinical Site

Prague, 160 00, Czechia

Location

Neurocrine Clinical Site

Belgrade, 11000, Serbia

Location

Neurocrine Clinical Site

Gornja Toponica, 18202, Serbia

Location

Neurocrine Clinical Site

Kovin, 26220, Serbia

Location

Neurocrine Clinical Site

Kragujevac, 34000, Serbia

Location

Neurocrine Clinical Site

Niš, 18101, Serbia

Location

Neurocrine Clinical Site

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 10, 2022
• Study Start: December 7, 2021
• Primary Completion: June 28, 2024
• Study Completion: October 14, 2024
• Last Updated: July 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); US (33); BU (7); ES (1); SE (5)