Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07184619 · ClinicalTrials.gov registry record · Phase 3
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
A Phase 3 study of Treatment-resistant Schizophrenia, sponsored by Newron Pharmaceuticals SPA.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 5
- Study locations
NCT07184619 is a Phase 3 study of Treatment-resistant Schizophrenia that is actively recruiting participants, run by Newron Pharmaceuticals SPA. The registered enrollment target is 400 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT07184619, a Phase 3 study of Treatment-resistant Schizophrenia, is actively recruiting participants, sponsored by Newron Pharmaceuticals SPA.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 5
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-01-23 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. 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 9 total studies on file at ClinicalTrials.gov.
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.
NCT07184619 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.
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.
What interventions are being tested in trial NCT07184619?
The interventions under investigation include: Placebo (DRUG), Evenamide 15 mg bid (DRUG).
Who is sponsoring clinical trial NCT07184619?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Treatment-resistant Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.