SchizophreniaPhase 2ERUDITENCT05182476
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
A Phase 2 study testing Luvadaxistat in people with Schizophrenia, run by Neurocrine Biosciences at 49 sites in 5 countries.
Trial summary
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Luvadaxistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 49 sitesin 5 countries
- Study dates
- 7 Dec 2021to 14 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
49 sites in 5 countries.
49 sites in 5 countries
United States33 sites
Neurocrine Clinical Site
Anaheim, California, 92805
Neurocrine Clinical Site
Ann Arbor, Michigan, 48105
Neurocrine Clinical Site
Atlanta, Georgia, 30338
Neurocrine Clinical Site
Aventura, Florida, 33180
Neurocrine Clinical Site
Bellflower, California, 90706
Neurocrine Clinical Site
Bentonville, Arkansas, 72712
Neurocrine Clinical Site
Bryant, Arkansas, 72022
Neurocrine Clinical Site
Cedarhurst, New York, 11516
Neurocrine Clinical Site
Chicago, Illinois, 60640
Neurocrine Clinical Site
DeSoto, Texas, 75115
Neurocrine Clinical Site
Flowood, Mississippi, 39232
Neurocrine Clinical Site
Garden Grove, California, 92845
Neurocrine Clinical Site
Glendale, California, 91206
Neurocrine Clinical Site
Houston, Texas, 77030
Neurocrine Clinical Site
Miami, Florida, 33016
Neurocrine Clinical Site
Miami, Florida, 33133
Neurocrine Clinical Site
Miami, Florida, 33144
Neurocrine Clinical Site
Miami, Florida, 33176
Neurocrine Clinical Site
New York, New York, 10032
Neurocrine Clinical Site
New York, New York, 10035
Neurocrine Clinical Site
Oceanside, California, 92056
Neurocrine Clinical Site
Okeechobee, Florida, 34972
Neurocrine Clinical Site
Pensacola, Florida, 32502
Neurocrine Clinical Site
Phoenix, Arizona, 85012
Neurocrine Clinical Site
Pico Rivera, California, 90660
Neurocrine Clinical Site
San Diego, California, 92102
Neurocrine Clinical Site
San Diego, California, 92103
Neurocrine Clinical Site
San Rafael, California, 94901
Neurocrine Clinical Site
St Louis, Missouri, 63128
Neurocrine Clinical Site
St Louis, Missouri, 63141
Neurocrine Clinical Site
Stanford, California, 94305
Neurocrine Clinical Site
Tampa, Florida, 33629
Neurocrine Clinical Site
Torrance, California, 90502
Bulgaria7 sites
Neurocrine Clinical Site
Pleven, 5800
Neurocrine Clinical Site
Plovdiv, 4004
Neurocrine Clinical Site
Sofia, 1000
Neurocrine Clinical Site
Sofia, 1113
Neurocrine Clinical Site
Sofia, 1408
Neurocrine Clinical Site
Sofia, 1510
Neurocrine Clinical Site
Sofia, 1680
Serbia5 sites
Neurocrine Clinical Site
Belgrade, 11000
Neurocrine Clinical Site
Gornja Toponica, 18202
Neurocrine Clinical Site
Kovin, 26220
Neurocrine Clinical Site
Kragujevac, 34000
Neurocrine Clinical Site
Niš, 18101
Czechia3 sites
Neurocrine Clinical Site
Pilsen, 301 00
Neurocrine Clinical Site
Prague, 100 00
Neurocrine Clinical Site
Prague, 160 00
About this study
Official title: 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.
Read the 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 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).
- Conditions
- Schizophrenia
- Being tested
- Placebo, Luvadaxistat
- Keywords
- Schizophrenia, Cognitive Impairment, Luvadaxistat, NBI-1065844, TAK-831, CIAS, BAC, ERUDITE, Neurocrine
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral tablets
LuvadaxistatDrug
Also called NBI-1065844, TAK-831
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo daily Receives: Drug: Placebo |
| Luvadaxistat treatment schedule 1 | Experimental | Luvadaxistat daily Receives: Drug: Luvadaxistat |
| Luvadaxistat treatment schedule 2 | Experimental | Luvadaxistat daily Receives: Drug: Luvadaxistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
Measured: Baseline, Day 98
Secondary outcomes (3)
Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score
Measured: Baseline, Day 98
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Measured: Baseline, Day 98
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
Measured: Baseline, Day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start7 Dec 2021
- Primary completion28 Jun 2024
- Study completion14 Oct 2024
Why it stopped: Failed to meet the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182476
- Sponsor's protocol ID
- NBI-1065844-CIAS2023
- Other IDs
- 2021-003834-34
- Acronym
- ERUDITE
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khin NA, Fan RH, Ge T, Klein HS, Ballon JS, Brar S, Harvey PD, Kantrowitz JT, Keefe RSE, Asgharnejad M, Murthy V, Roberts E, Singh JB. A phase 2 randomized controlled trial of luvadaxistat in treatment of adults with cognitive impairment associated with schizophrenia: results from the ERUDITE study. Neuropsychopharmacology. 2026 Apr 24. doi: 10.1038/s41386-026-02410-5. Online ahead of print.
PubMed 42032293