Study to Determine the Safety Tolerability and Preliminary Evidence of Efficacy of Evenamide in Patients With Chronic Schizophrenia

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Newron Pharmaceuticals SPA
Updated on 1 March 2021
antipsychotics
olanzapine
clozapine
aripiprazole
risperidone
quetiapine
paliperidone
chronic schizophrenia

Summary

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

Description

This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed oral doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic schizophrenia who are receiving treatment at constant doses of one of the following atypical antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone. Approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide 7.5 or 15 mg, or placebo, given bid.

Details
Condition Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders
Treatment Placebo, Evenamide
Clinical Study IdentifierNCT04461119
SponsorNewron Pharmaceuticals SPA
Last Modified on1 March 2021

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