Evenamide, a Glutamate Release Modulator, as Add-On to St... | NCT07184619

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evenamide 15 mg bid	Experimental	Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment	Drug: Evenamide 15 mg bid
Placebo	Placebo Comparator	Matching placebo capsules bid for a total of 12 weeks of add-on treatment	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Evenamide 15 mg bid	Drug	Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment	Evenamide 15 mg bid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).	Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).	From Baseline to Week 12
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).	Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).	From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.	Efficacy measured by the mean change from baseline to endpoint on the Clinical Global Impression Severity of Illness (CGI-S) scale: a 7-point scale ranging from 1 (no symptoms) to 7 (very severe) to assess the severity of a subject's condition.	From Baseline to Week 12

Other Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint (Week 12) on the Negative Symptoms sub-scale score of the PANSS.	Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: this is a 7-item subscale that was designed to assess negative symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).	From Baseline to Week 12.

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Newron Pharmaceuticals	Contact	+39 02 610 3461		info@newron.com

Name	Affiliation	Role
Ravi Anand, MD	Newron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCLA DGSOM, UCLA Health, UCLA Semel Institute	Suspended	Los Angeles	California	90095	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39708914	Background	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.
39661380

ID	Term
D000090663	Schizophrenia, Treatment-Resistant
D012559	Schizophrenia

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders