Recruiting
Phase 3

Evenamide

Sponsor:

Newron Pharmaceuticals SPA

Code:

NCT07184619

Conditions

Treatment-resistant Schizophrenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evenamide 15 mg bid

Placebo

Study Details

Brief 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

Study ID

NCT07184619

Start date

Jan 23, 2026

Status verified date

Apr, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Age - 18 years, or older.
  • If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
  • Meets current DSM-5-TR criteria for schizophrenia.
  • Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
  • Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
  • Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
  • Has a BPRS total score ≥ 45 at screening and baseline.
  • Has a PANSS total score ≥ 70 at baseline.
  • Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
  • Adherence to prescribed antipsychotic treatment.
  • Patient has provided written informed consent prior to participating in the study.

Key Exclusion Criteria:

  • Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
  • History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
  • Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
  • History or current diagnosis of other psychiatric or behavioral disorders.
  • Known suicidal risk, or a suicide attempt within the past 2 years.
  • History of neuroleptic malignant syndrome or priapism.
  • Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
  • History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Evenamide 15 mg bid

Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment

placebo comparator: Placebo

Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Interventions

Evenamide 15 mg bid

Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment

Placebo

Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Primary outcome measure

  • Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS). [ Time Frame: From Baseline to Week 12 ]
  • Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs). [ Time Frame: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up) ]

Central Contacts and Locations

Central contacts

Newron Pharmaceuticals

+39 02 610 3461info@newron.com

Locations

UCLA DGSOM, UCLA Health, UCLA Semel Institute

Recruiting

Los Angeles, California, United States, 90095

Contacts

Site contact

310-478-3711GDeVera@mednet.ucla.edu

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

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Site contact

410-343-9434melashr1@jh.edu

Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research

Recruiting

New York, New York, United States, 10035

Contacts

Site contact

212-866-2690benedicto.parker@nki.rfmh.org

More Information

Sponsor

Newron Pharmaceuticals SPA

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • evenamide
  • treatment-resistant schizophrenia
  • antipsychotic
  • schizophrenia
  • TRS
  • add-on treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Newron Pharmaceuticals SPA on 2026-04-03.