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Luvadaxistat for Schizophrenia (ERUDITE Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 98
Awards & highlights

ERUDITE Trial Summary

This trial will compare the effects of luvadaxistat versus placebo on cognitive performance in people with schizophrenia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typically such trials monitor for any adverse reactions ranging from mild (headaches, nausea) to severe (allergic reactions). The safety profile of Luvadaxistat will be closely observed.

ERUDITE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old and can follow all study procedures.
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I have been diagnosed with schizophrenia.
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I was diagnosed with schizophrenia over a year ago.
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I am on a stable dose of medication for my mental health.
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My symptoms have been stable for at least 3 months.
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I weigh at least 45 kg and my BMI is between 18.0 and 45.0.

ERUDITE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 98
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 98 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Schizophrenia
Secondary outcome measures
Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score
Schizophrenia
Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

ERUDITE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Luvadaxistat treatment schedule 2Experimental Treatment1 Intervention
Luvadaxistat daily
Group II: Luvadaxistat treatment schedule 1Experimental Treatment1 Intervention
Luvadaxistat daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luvadaxistat
2018
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,551 Total Patients Enrolled
11 Trials studying Schizophrenia
1,753 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,377 Total Patients Enrolled
4 Trials studying Schizophrenia
1,073 Patients Enrolled for Schizophrenia

Media Library

Luvadaxistat (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05182476 — Phase 2
Schizophrenia Research Study Groups: Luvadaxistat treatment schedule 2, Luvadaxistat treatment schedule 1, Placebo
Schizophrenia Clinical Trial 2023: Luvadaxistat Highlights & Side Effects. Trial Name: NCT05182476 — Phase 2
Luvadaxistat (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182476 — Phase 2
Schizophrenia Patient Testimony for trial: Trial Name: NCT05182476 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being accepted for this trial?

"This research effort, which was initially publicized on December 7th 2021, is actively seeking participants. Updates to the study were made as recently as November 9th 2022 according to clinicaltrials.gov"

Answered by AI

How many participants are actively enrolled in this research initiative?

"Affirmative. According to the clinicaltrials.gov database, this trial is currently recruiting patients as of November 9th 2022 - a year after it was initially posted on December 7th 2021. The study requires 308 participants from 24 sites in total."

Answered by AI

Has Luvadaxistat been authorized by the US Food and Drug Administration?

"Luvadaxistat's safety was rated at 2, as the current research is limited to Phase 2 trials so far and has not yielded any data concerning its efficacy."

Answered by AI

Is it possible to join the experiment?

"This research venture is searching for 308 individuals with a diagnosis of schizophrenia, aged between 18 and 50. To be eligible to participate, they must have been diagnosed ≥1 year before screening, possess written informed consent, meet the criteria outlined in the DSM-5 regarding this disorder, maintain stable symptomology over 3 months prior to enrollment and an adult informant that can confirm their condition. Moreover, participants are expected to weigh at least 45 kilograms (kg) and present a body mass index (BMI) ranging from 18.0 kg/m^2 to 45.0 kg/m^2"

Answered by AI

How many venues are being utilized to conduct this experiment?

"This medical trial is currently running out of 24 different sites, with locations in Boston, Houston and Cedarhurst amongst others. To limit travel needs for participants, it is wise to select the nearest site when enrolling in this study."

Answered by AI

Is this experiment open to octogenarians?

"This medical trial has an age criterion of 18 to 50 years old and will only accept participants within this range."

Answered by AI

Who else is applying?

What state do they live in?
California
Arizona
What site did they apply to?
Neurocrine Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I need help for my condition. I need help I can’t stand the voices & visions anymore please help me thanks.
PatientReceived no prior treatments
I have been on a lot of different medications and none of them have worked as well.
PatientReceived no prior treatments
I have been on a lot of different medications and none of them have worked as well as I wou l d have liked.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Neurocrine Clinical Site: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
2021. "Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05182476.
All > Schizophrenia
~60 spots leftby Apr 2025
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