NCT07184619

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Treatment-resistant Schizophrenia

Interventions

Type	Name	Description
DRUG	Evenamide 15 mg bid	Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
DRUG	Placebo	Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Timeline

• Start date: 2026-01-23
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-09-22
• Last updated: 2026-04-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study