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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Behavioral Research Specialists, LLC
Glendale, California, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Community Clinical Research CCR
Austin, Texas, United States
Help Hospitals Clinical Research Department
Vijayawada, Andhra Pradesh, India
St. John's Medical College Hospital
Koramangala, Karnataka, India
Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry
Mangalore, Karnataka, India
IQRAA Psychiatry Care and Rehabilitation Centre
Kozhikode, Kerala, India
Deenanath Mangeshkar Hospital Research Center
Pune, Maharashtra, India
Sujata Birla Hospital
Pune, Maharashtra, India
Post Graduate Institute of Medical Education and Research
Chandigarh, Punjab, India
Start Date
June 16, 2020
Primary Completion Date
February 20, 2021
Completion Date
March 13, 2021
Last Updated
May 20, 2021
138
ACTUAL participants
Evenamide
DRUG
Placebo
DRUG
Lead Sponsor
Newron Pharmaceuticals SPA
NCT07455929
NCT06740383
Data Source & Attribution
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