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

Neurocrine Biosciences

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Luvadaxistat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05182476

NBI-1065844-CIAS2023

2021-003834-34 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 216 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo daily

Treatment:

Drug: Placebo

Luvadaxistat treatment schedule 1

Experimental group

Description:

Luvadaxistat daily

Treatment:

Drug: Luvadaxistat

Luvadaxistat treatment schedule 2

Experimental group

Description:

Luvadaxistat daily

Treatment:

Drug: Luvadaxistat