Clinical Trial

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

Study acronym: ENIGMA-TRS 2
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 10 -> 15 locations 2026-07-31
notable Trial sites expanded: 5 -> 10 locations 2026-06-05
notable Primary completion pushed: 2026-09-01 -> 2026-12-31 2026-06-05
minor Completion pushed: 2026-09-01 -> 2026-12-31 2026-06-05
Trial Details
NCT Number NCT07184619
Lead Sponsor Newron Pharmaceuticals SPA
Conditions Treatment-resistant Schizophrenia
Enrollment 400 participants
Start Date 2026-01-23
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30