Luvadaxistat for Schizophrenia

(ERUDITE Trial)

No longer recruiting at 67 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocrine Biosciences

Must be taking: Psychotropic medications

Disqualifiers: Pregnancy, Extrapyramidal symptoms, Schizoaffective, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called luvadaxistat to determine if it can improve thinking and memory in people with schizophrenia. The study compares luvadaxistat to a placebo (a pill with no active medicine) to assess its effectiveness and safety. It seeks participants who have had schizophrenia for at least a year and are on a stable medication plan. Those who fit this description might be good candidates for the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important advancements in schizophrenia treatment.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable regimen of psychotropic medications, so you will not need to stop taking your current medications if they are stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that luvadaxistat is generally safe for people. In earlier studies, most participants tolerated it well, and no major safety issues arose. Some studies even reported improvements in certain symptoms with a 50 mg dose. Although luvadaxistat did not always meet its primary goals for symptom improvement, safety data indicates it can be used without major side effects. This information can reassure those considering joining a trial about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Researchers are excited about Luvadaxistat for schizophrenia because it works differently from most existing treatments. While standard medications like antipsychotics typically target dopamine receptors, Luvadaxistat focuses on inhibiting an enzyme called D-amino acid oxidase (DAAO). This unique action may help in modulating neurotransmitter levels more precisely, potentially offering benefits in symptom control and reducing side effects commonly associated with traditional therapies. This novel approach gives hope for improved quality of life for those living with schizophrenia.

What evidence suggests that luvadaxistat might be an effective treatment for schizophrenia?

Research has shown that luvadaxistat, a drug under study for schizophrenia in this trial, might help improve thinking and memory. One study found that taking 50 mg of luvadaxistat led to better results on tests measuring these abilities. However, another study did not achieve its main goal of improving cognitive problems in schizophrenia. Despite these mixed results, a larger review suggests that luvadaxistat and similar drugs could help with thinking and other symptoms of schizophrenia. While the findings are not conclusive, some evidence indicates that luvadaxistat may assist with cognitive issues in this condition. Participants in this trial will receive either luvadaxistat or a placebo to further evaluate its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with schizophrenia diagnosed at least a year ago, stable symptoms for 3+ months, and on steady psychotropic meds. They need an adult informant, weigh at least 45 kg with a BMI of 18-45. Excluded are pregnant individuals, those with recent substance abuse or severe mental health risks.

Inclusion Criteria

Do you feel numb or less interested in things you once enjoed?

Have you tried at least one antidepressant that hasn't worked?

Are you currently taking Citalopram?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive luvadaxistat or placebo daily to evaluate efficacy, safety, and tolerability

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive luvadaxistat in an open-label extension phase

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Luvadaxistat
• Placebo

Trial Overview The study tests Luvadaxistat's ability to improve cognitive performance in schizophrenia patients against a placebo. Participants will be randomly assigned to receive either the drug or placebo while their cognitive changes are monitored.

How Is the Trial Designed?

Group I: Luvadaxistat treatment schedule 2 Experimental Treatment 1 Intervention

Luvadaxistat daily

Group II: Luvadaxistat treatment schedule 1 Experimental Treatment 1 Intervention

Luvadaxistat daily

Group III: Placebo Placebo Group 1 Intervention

Placebo daily

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38943928/

a randomized phase 2 study of the DAAO inhibitor ... Luvadaxistat did not significantly improve negative symptoms of schizophrenia. However, luvadaxistat 50 mg met the prespecified secondary endpoints for ...

2. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-provides-update-eruditetm-phase-2-data

Neurocrine Biosciences Provides Update on ERUDITE ... In the INTERACT study, 50 mg luvadaxistat resulted in a statistically significant improvement in measure of cognition on the Brief Assessment ...

3. nature.com nature.com/articles/s41537-025-00604-2

a meta-analysis of double-blind randomized controlled trials The findings of this meta-analysis suggest that DAOI may be effective in improving clinical symptoms and cognitive function in patients with schizophrenia.

4. prnewswire.com prnewswire.com/news-releases/neurocrine-biosciences-provides-update-on-erudite-phase-2-data-for-luvadaxistat-in-adults-with-cognitive-impairment-associated-with-schizophrenia-302246962.html

Neurocrine Biosciences Provides Update on ERUDITE™ ... Luvadaxistat (NBI-1065844) failed to meet its primary endpoint as a potential treatment to improve cognitive impairment in patients with schizophrenia.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03382639

NCT03382639 | A Study to Evaluate 3 Dose Levels of ... The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018616/

The D-amino acid oxidase inhibitor luvadaxistat improves ... The D-amino acid oxidase inhibitor luvadaxistat improves mismatch negativity in patients with schizophrenia in a randomized trial · Abstract.