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NCT05182476 Clinical Trial

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

Schizophrenia Clinical Trial

— ERUDITE  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05182476
Other study ID # NBI-1065844-CIAS2023
Secondary ID 2021-003834-34
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 7, 2021
Est. completion date March 2025

Study information
Verified date April 2024
Source Neurocrine Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date March 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Oral tablets
• Luvadaxistat
Oral tablets

Locations
Country Name City State
Bulgaria Neurocrine Clinical Site Pleven
Bulgaria Neurocrine Clinical Site Plovdiv
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Sofia
Bulgaria Neurocrine Clinical Site Vratsa
Czechia Neurocrine Clinical Site Plzen
Czechia Neurocrine Clinical Site Praha 10
Czechia Neurocrine Clinical Site Praha 6
Mexico Neurocrine Clinical Site Culiacan
Mexico Neurocrine Clinical Site Guadalajara
Mexico Neurocrine Clinical Site Leon
Mexico Neurocrine Clinical Site Monterrey
Mexico Neurocrine Clinical Site Monterrey
Mexico Neurocrine Clinical Site San Luis Potosí
Serbia Neurocrine Clinical Site Belgrade
Serbia Neurocrine Clinical Site Gornja Toponica
Serbia Neurocrine Clinical Site Kovin
Serbia Neurocrine Clinical Site Kragujevac
Serbia Neurocrine Clinical Site Nis
Serbia Neurocrine Clinical Site Novi Kneževac
Spain Neurocrine Clinical Site Barcelona
Spain Neurocrine Clinical Site Barcelona
Spain Neurocrine Clinical Site Madrid
Spain Neurocrine Clinical Site Madrid
Spain Neurocrine Clinical Site Madrid
Spain Neurocrine Clinical Site Sabadell
United States Neurocrine Clinical Site Anaheim California
United States Neurocrine Clinical Site Ann Arbor Michigan
United States Neurocrine Clinical Site Atlanta Georgia
United States Neurocrine Clinical Site Aventura Florida
United States Neurocrine ClinicalSite Bellflower California
United States Neurocrine Clinical Site Bentonville Arkansas
United States Neurocrine Clinical Site Bonita Springs Florida
United States Neurocrine Clinical Site Boston Massachusetts
United States Neurocrine Clinical Site Bryant Arkansas
United States Neurocrine Clinical Site Cedarhurst New York
United States Neurocrine Clinical Site Charlotte North Carolina
United States Neurocrine Clinical Site Chicago Illinois
United States Neurocrine Clinical Site Chicago Illinois
United States Neurocrine Clinical Site Coral Gables Florida
United States Neurocrine Clinical Site Culver City California
United States Neurocrine Clinical Site DeSoto Texas
United States Neurocrine Clinical Site Fairlawn Ohio
United States Neurocrine Clinical Site Flowood Mississippi
United States Neurocrine Clinical Site Garden Grove California
United States Neurocrine Clinical Site Glendale California
United States Neurocrine Clinical Site Grand Rapids Michigan
United States Neurocrine Clinical Site Homestead Florida
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Long Beach California
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site New York New York
United States Neurocrine Clinical Site New York New York
United States Neurocrine Clinical Site North Dartmouth Massachusetts
United States Neurocrine Clinical Site North Miami Florida
United States Neurocrine Clinical Site Oceanside California
United States Neurocrine Clinical Site Okeechobee Florida
United States Neurocrine Clinical Site Orange City Florida
United States Neurocrine Clinical Site Orlando Florida
United States Neurocrine Clinical Site Pensacola Florida
United States Neurocrine Clinical Site Phoenix Arizona
United States Neurocrine Clinical Site Pico Rivera California
United States Neurocrine Clinical Site Riverside California
United States Neurocrine Clinical Site Saint Louis Missouri
United States Neurocrine Clinical Site Saint Louis Missouri
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Rafael California
United States Neurocrine Clinical Site Santa Ana California
United States Neurocrine Clinical Site Stony Brook New York
United States Neurocrine Clinical Site Tampa Florida
United States Neurocrine Clinical Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Mexico,  Serbia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score Baseline, Day 98
Secondary Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score Baseline, Day 98
Secondary Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Baseline, Day 98
Secondary Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score Baseline, Day 98
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