RecruitingPhase 3NCT07184619

Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia

A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)


Sponsor

Newron Pharmaceuticals SPA

Enrollment

400 participants

Start Date

Jan 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing evenamide, an experimental drug that reduces excess glutamate (a brain chemical) in people with schizophrenia who have not responded to other antipsychotic treatments. It is added on top of the patient's current medications. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of schizophrenia - You have tried multiple antipsychotic medications and they haven't worked well enough - You are currently taking at least one antipsychotic medication at a recommended dose - Your symptoms are at least moderately severe **You may NOT be eligible if...** - You have a different primary psychiatric diagnosis (e.g., bipolar disorder, schizoaffective disorder) - You have had a substance use disorder in the past 3 months - You have epilepsy or have had a seizure in the past year - You have attempted suicide in the past 2 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEvenamide 15 mg bid

Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment

DRUGPlacebo

Matching placebo capsules bid for a total of 12 weeks of add-on treatment


Locations(5)

UCLA DGSOM, UCLA Health, UCLA Semel Institute

Los Angeles, California, United States

University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital

Miami, Florida, United States

Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine

Atlanta, Georgia, United States

Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07184619


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