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Luvadaxistat for Schizophrenia (ERUDITE Trial)
Verified Trial
Phase 2
Waitlist Available
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 up to 5 years
Summary
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.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily involve antipsychotic medications, which are categorized into first-generation (typical) and second-generation (atypical) antipsychotics. These drugs mainly target dopamine D2 receptors to reduce psychotic symptoms by decreasing dopamine activity.
However, cognitive deficits in schizophrenia are not fully addressed by these treatments. Luvadaxistat, a D-amino acid oxidase inhibitor, aims to enhance NMDA receptor function by increasing D-serine levels, a co-agonist of the NMDA receptor.
This approach is significant as it targets glutamatergic dysfunction, which is believed to contribute to cognitive impairments in schizophrenia, offering a potential avenue for improving cognitive outcomes in patients.
Glutamatergic drugs for schizophrenia.
Glutamatergic drugs for schizophrenia.
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Who is running the clinical trial?
Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,129 Total Patients Enrolled
11 Trials studying Schizophrenia
1,358 Patients Enrolled for Schizophrenia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
1,982 Total Patients Enrolled
4 Trials studying Schizophrenia
678 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently been diagnosed with a panic disorder, depression, or another psychiatric condition.I am on a stable dose of medication for my mental health.I weigh at least 45 kg and my BMI is between 18.0 and 45.0.You have any physical or mental condition that could make it difficult for you to participate in the study or complete the required assessments.I am between 18 and 50 years old and can follow all study procedures.I was diagnosed with schizophrenia over a year ago.I have been diagnosed with schizophrenia.I was diagnosed with schizophrenia before I turned 12.My symptoms have been stable for at least 3 months.You have been diagnosed with certain mental health conditions including schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder at any point in your life.
Research Study Groups:
This trial has the following groups:- Group 1: Luvadaxistat treatment schedule 2
- Group 2: Luvadaxistat treatment schedule 1
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05182476 — Phase 2