Clinical trial NCT05182476: Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive Impairment
Luvadaxistat
NBI-1065844
TAK-831
CIAS
BAC
ERUDITE
Neurocrine
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
timeFrame: Baseline, Day 98
Secondary outcomes:
measure: Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
timeFrame: Baseline, Day 98
measure: Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
timeFrame: Baseline, Day 98
measure: Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
timeFrame: Baseline, Day 98
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Neurocrine Clinical Site
state: Arizona
city: Bentonville
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Bryant
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Bellflower
country: United States
facility: Neurocrine Clinical Site
state: California
city: Garden Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Glendale
country: United States
facility: Neurocrine Clinical Site
state: California
city: Oceanside
country: United States
facility: Neurocrine Clinical Site
state: California
city: Pico Rivera
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Rafael
country: United States
facility: Neurocrine Clinical Site
state: California
city: Stanford
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Aventura
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Okeechobee
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Pensacola
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Tampa
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Ann Arbor
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Flowood
country: United States
facility: Neurocrine Clinical Site
state: Mississippi
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Cedarhurst
country: United States
facility: Neurocrine Clinical Site
state: New York
city: New York
country: United States
facility: Neurocrine Clinical Site
state: New York
city: New York
country: United States
facility: Neurocrine Clinical Site
state: New York
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Pleven
country: Bulgaria
facility: Neurocrine Clinical Site
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Plzen
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 10
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 6
country: Czechia
facility: Neurocrine Clinical Site
city: Belgrade
country: Serbia
facility: Neurocrine Clinical Site
city: Gornja Toponica
country: Serbia
facility: Neurocrine Clinical Site
city: Kovin
country: Serbia
facility: Neurocrine Clinical Site
city: Kragujevac
country: Serbia
facility: Neurocrine Clinical Site
city: Nis
country: Serbia
facility: Neurocrine Clinical Site
city: Madrid
country: Spain
facility: Neurocrine Clinical Site
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: