Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
NCT ID: NCT05182476
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
216 participants
INTERVENTIONAL
2021-12-07
2024-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo daily
Placebo
Oral tablets
Luvadaxistat treatment schedule 1
Luvadaxistat daily
Luvadaxistat
Oral tablets
Luvadaxistat treatment schedule 2
Luvadaxistat daily
Luvadaxistat
Oral tablets
Interventions
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Placebo
Oral tablets
Luvadaxistat
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Phoenix, Arizona, United States
Neurocrine Clinical Site
Bentonville, Arkansas, United States
Neurocrine Clinical Site
Bryant, Arkansas, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Bellflower, California, United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Glendale, California, United States
Neurocrine Clinical Site
Oceanside, California, United States
Neurocrine Clinical Site
Pico Rivera, California, 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
Stanford, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Aventura, 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
Okeechobee, Florida, United States
Neurocrine Clinical Site
Pensacola, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Flowood, Mississippi, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
Neurocrine Clinical Site
Cedarhurst, New York, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
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
Pilsen, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Belgrade, , Serbia
Neurocrine Clinical Site
Gornja Toponica, , Serbia
Neurocrine Clinical Site
Kovin, , Serbia
Neurocrine Clinical Site
Kragujevac, , Serbia
Neurocrine Clinical Site
Niš, , Serbia
Neurocrine Clinical Site
Madrid, , Spain
Countries
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Other Identifiers
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2021-003834-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NBI-1065844-CIAS2023
Identifier Type: -
Identifier Source: org_study_id
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