Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
NCT ID: NCT07184619
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-10-15
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Evenamide 15 mg bid
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
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
Placebo
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Newron Pharmaceuticals SPA
INDUSTRY
Responsible Party
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Principal Investigators
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Ravi Anand, MD
Role: STUDY_DIRECTOR
Newron Pharmaceuticals
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Anand R, Turolla A, Chinellato G, Sansi F, Roy A, Hartman R. Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. Neuropharmacology. 2025 Mar 15;266:110275. doi: 10.1016/j.neuropharm.2024.110275. Epub 2024 Dec 19.
Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Therapeutic Effect of Evenamide, a Glutamate Inhibitor, in Patients With Treatment-Resistant Schizophrenia (TRS): Final, 1-Year Results From a Phase 2, Open-Label, Rater-Blinded, Randomized, International Clinical Trial. Int J Neuropsychopharmacol. 2024 Dec 28;28(1):pyae061. doi: 10.1093/ijnp/pyae061.
Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Phase 2 Results Indicate Evenamide, A Selective Modulator of Glutamate Release, Is Associated With Clinically Important Long-Term Efficacy When Added to an Antipsychotic in Patients With Treatment-Resistant Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):523-528. doi: 10.1093/ijnp/pyad035.
Other Identifiers
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NW-3509/022/III/2024
Identifier Type: -
Identifier Source: org_study_id
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