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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Newron Pharmaceuticals SPA
Study ID
NCT07184619
Phase
PHASE3
Status
Recruiting
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Conditions

  • Treatment-resistant Schizophrenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA DGSOM, UCLA Health, UCLA Semel InstituteLos AngelesCalifornia90095-
University of Miami, Miller School of Medicine; Jackson Behavioral Health HospitalMiamiFlorida33136-
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of MedicineAtlantaGeorgia30322-
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of MedicineBaltimoreMaryland21224-
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric ResearchNew YorkNew York10035-

Find similar trials in Los Angeles, CA

By research site
UCLA DGSOM, UCLA Health, UCLA Semel Institute· Los Angeles, CAUniversity of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital· Miami, FLGrady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine· Atlanta, GADepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine· Baltimore, MDManhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research· New York, NY

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