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RECRUITING Phase 3

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

NCT07184619 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Evenamide 15 mg bid

Study Locations (5)

California

  • UCLA DGSOM, UCLA Health, UCLA Semel Institute — Los Angeles

Florida

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

Georgia

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

Maryland

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

New York

  • Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research — New York

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2026-01-23
Est. Completion 2026-09-01
Phase Phase 3

Sponsor

Newron Pharmaceuticals SPA

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07184619

The ClinicalTrials.gov registry entry for NCT07184619 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newron Pharmaceuticals SPA, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Treatment-resistant Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07184619 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07184619 about?

NCT07184619 is a clinical study titled "Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia". 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 p...

What is the current status of trial NCT07184619?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2026-01-23. Estimated completion is 2026-09-01.

What conditions does trial NCT07184619 study?

This clinical trial studies the following conditions: Treatment-resistant Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07184619?

The interventions under investigation include: Placebo (DRUG), Evenamide 15 mg bid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07184619?

This trial is sponsored by Newron Pharmaceuticals SPA, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07184619 being conducted?

This trial has 5 study locations across California, Florida, Georgia, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial