Luvadaxistat for Schizophrenia

(ERUDITE Trial)

Recruiting at 63 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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a daily pill called luvadaxistat to see if it can help people with schizophrenia think and remember better. Researchers want to find out if luvadaxistat is safe and effective for improving cognitive problems in these patients.

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.

Research Team

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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