For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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.

EXCLUSION CRITERIA

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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Schizophrenia

Age (in years)

18 - 50

Phase

Phase 2

Participants needed

200

Est. Completion Date

Mar 31, 2025

Treatment type

Interventional


Sponsor

Neurocrine Biosciences

ClinicalTrials.gov identifier

NCT05182476

Study number

NBI-1065844-CIAS2023

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