Status:
TERMINATED
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 pharmac...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Participants must meet all of the following inclusion criteria:
- Completed written informed consent.
- Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
- Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The initial diagnosis of schizophrenia must be ≥1 year before screening.
- The participant is currently receiving a stable regimen of psychotropic medications.
- Participant has stable symptomatology ≥3 months before the screening visit.
- The participant must have an adult informant.
- 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:
- Pregnant or breastfeeding or plans to become pregnant during the study.
- Exhibit more than a minimal level of extrapyramidal signs/symptoms.
- Schizophrenia diagnosis occurred before 12 years of age.
- Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
- Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
- 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.
- Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
- Positive drug screen for disallowed substances.
- Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.
Exclusion
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05182476
Start Date
December 7 2021
End Date
October 14 2024
Last Update
July 2 2025
Active Locations (49)
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1
Neurocrine Clinical Site
Phoenix, Arizona, United States, 85012
2
Neurocrine Clinical Site
Bentonville, Arkansas, United States, 72712
3
Neurocrine Clinical Site
Bryant, Arkansas, United States, 72022
4
Neurocrine Clinical Site
Anaheim, California, United States, 92805