Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
Megadott ok: Failed to meet the primary endpoint
Key facts
- Where
- Anaheim, Ann Arbor, Atlanta, Aventura, Bellflower, Bentonville, Bryant, Cedarhurst, Chicago, DeSoto, Flowood, Garden Grove, Glendale, Houston, Miami, New York, Oceanside, Okeechobee, Pensacola, Phoenix, Pico Rivera, San Diego, San Rafael, St Louis, Stanford, Tampa és Torrance, Egyesült ÁllamokSee the 27 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- AnaheimAnaheim, Egyesült ÁllamokNo longer taking part
- Ann ArborAnn Arbor, Egyesült ÁllamokNo longer taking part
- AtlantaAtlanta, Egyesült ÁllamokNo longer taking part
- AventuraAventura, Egyesült ÁllamokNo longer taking part
- BellflowerBellflower, Egyesült ÁllamokNo longer taking part
- BentonvilleBentonville, Egyesült ÁllamokNo longer taking part
- BryantBryant, Egyesült ÁllamokNo longer taking part
- CedarhurstCedarhurst, Egyesült ÁllamokNo longer taking part
- ChicagoChicago, Egyesült ÁllamokNo longer taking part
- DeSotoDeSoto, Egyesült ÁllamokNo longer taking part
- FlowoodFlowood, Egyesült ÁllamokNo longer taking part
- Garden GroveGarden Grove, Egyesült ÁllamokNo longer taking part
- GlendaleGlendale, Egyesült ÁllamokNo longer taking part
- HoustonHouston, Egyesült ÁllamokNo longer taking part
- MiamiMiami, Egyesült ÁllamokNo longer taking part
- New YorkNew York, Egyesült ÁllamokNo longer taking part
- OceansideOceanside, Egyesült ÁllamokNo longer taking part
- OkeechobeeOkeechobee, Egyesült ÁllamokNo longer taking part
- PensacolaPensacola, Egyesült ÁllamokNo longer taking part
- PhoenixPhoenix, Egyesült ÁllamokNo longer taking part
- Pico RiveraPico Rivera, Egyesült ÁllamokNo longer taking part
- San DiegoSan Diego, Egyesült ÁllamokNo longer taking part
- San RafaelSan Rafael, Egyesült ÁllamokNo longer taking part
- St LouisSt Louis, Egyesült ÁllamokNo longer taking part
- StanfordStanford, Egyesült ÁllamokNo longer taking part
- TampaTampa, Egyesült ÁllamokNo longer taking part
- TorranceTorrance, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT05182476
- Record updated
- 2025. július 2.
- Original description
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.Read full original descriptionShow less
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 to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
Inclusion: 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.
Exclusion: 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; Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder; Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions; Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments; Schizophrenia diagnosis occurred before 12 years of age; 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.