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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07184619

Public ClinicalTrials.gov record NCT07184619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 12:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07184619
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Newron Pharmaceuticals SPA
Industry
Enrollment
400 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 22, 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026
Last update posted
Jul 29, 2026

2026

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
UCLA DGSOM, UCLA Health, UCLA Semel Institute Los Angeles California 90095 Suspended
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital Miami Florida 33136 Suspended
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine Atlanta Georgia 30322 Suspended
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine Baltimore Maryland 21224 Suspended
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research New York New York 10035 Suspended

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07184619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 29, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07184619 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →