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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Newron Pharmaceuticals SPA • ClinicalTrials.gov ID: NCT07184619

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Evenamide 15 mg bid (Drug)
    Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
  • Placebo (Drug)
    Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Eligibility criteria

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.

Conditions

Treatment-resistant Schizophrenia

Locations

  • UCLA DGSOM, UCLA Health, UCLA Semel Institute — Los Angeles, California, United States
  • University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital — Miami, Florida, United States
  • Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine — Atlanta, Georgia, United States
  • Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
  • Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research — New York, New York, United States
  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales — Buenos Aires, Buenos Aires F.D., Argentina
  • Help Hospital — Vijayawada, Andhra Pradesh, India
  • Gauhati Medical College and Hospital — Guwahati, Assam, India
  • Masina Hospital Trust — Mumbai, Maharashtra, India
  • All India Institute Of Medical Sciences — Nagpur, Maharashtra, India
  • New Manak Healthcare Hospital — Navi Mumbai, Maharashtra, India
  • Ahana Hospitals LLP — Madurai, Tamil Nadu, India
  • All India Institute of Medical Sciences — Bībīnagar, Telangana, India
  • Udyan Health Care — Lucknow, Uttar Pradesh, India
  • Seth Sukhlal Karnani Memorial Hospital — Kolkata, West Bengal, India
  • Kuala Lumpur Hospital — Kuala Lumpur, Kuala Lumpur, Malaysia
  • Hospital Tuanku Fauziah — Kangar, Malaysia
  • Sentosa Hospital — Kuching, Malaysia
  • Sultan Abdul Halim Hospital — Sungai Petani, Malaysia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record