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
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

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