NCT04461119

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

A Phase II, Randomized, 4-Week, Double-Blind, Placebo-Controlled, Multiple-Dose Study, Designed to Determine the Safety, Tolerability, EEG Effects and Preliminary Efficacy of Fixed Oral Doses of 7.5 and 15 MG BID of Evenamide in Patients With Chronic Schizophrenia Who Are Symptomatic on Their Current Second-Generation Antipsychotic Medication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Evenamide	oral capsules for 4 weeks of treatment
DRUG	Placebo	oral capsules for 4 weeks of treatment

Timeline

• Start date: 2020-06-16
• Primary completion: 2021-02-20
• Completion: 2021-03-13
• First posted: 2020-07-08
• Last updated: 2021-05-20

Locations

14 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study