A Phase II/III, randomized, 4-week, placebo-controlled study, designed to determine the safety, tolerability, and efficacy of evenamide (NW-3509) in patients with chronic schizophrenia
- Conditions
- Chronic schizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-006062-36-IT
- Lead Sponsor
- EWRON PHARMACEUTICALS SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 196
-Age - 18 years, or older
-Female subjects must have a negative pregnancy test at the screening visit and at baseline and must not be lactating (If of childbearing potential, the subject must use a highly effective method of contraception (i.e., a method that can achieve a failure rate of less than 1% per year when used consistently and correctly) during the trial, from at least 28 days before the first dose until the final follow-up visit. A woman is considered to be of non-childbearing potential if she is post-menopausal , or has no uterus, ovaries or fallopian tubes. Women who are taking hormone replacement therapy (HRT) must use contraception during the trial.)
- Male subjects who are not sterilized must agree to not have sex without using a condom, if their partner
is a woman of childbearing potential, during the trial (from the first dose until the final follow-up visit). Male subjects must also agree not to attempt to father a child and must not donate sperm from the first dose until the final follow-up visit.
- Body mass index (BMI) of at least 17.5 and less than 35.
-Has a current diagnosis of schizophrenia in accordance with DSM-5. Other Axis-I disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia.
-Has been treated with antipsychotics for at least 2 years.
-Has a total score on the PANSS =70 and =85.
-Has a score of 4 (moderate) or more on at least 2 of the following 4 core symptoms of psychosis: conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; and a total score of at least 20 on the combined total of the 4 core items and the following 3 additional positive symptoms items: grandiosity, hostility, and excitement (based on the PANSS descriptions).
-Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately, moderately severely, or severely ill (score of 4, 5 or 6).
-Needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent).
-Current symptoms have been stably present for at least one month
-Patient has provided written informed consent prior to participating in the study.
-Patient is able to take oral medication and is willing to complete all protocol-defined aspects of the study.
-Patient resides at home or in a residential care facility with a caregiver who is available to ensure compliance with dosing and scheduled office visits.
-Patient agrees to be hospitalized overnight if required for trial purposes or if the investigator deems it
necessary to ensure the safety of the patient.
-If taking clozapine, patient agrees to blood monitoring (venipuncture for measuring ANC) weekly during their first 6 months of clozapine treatment, every 2 weeks from 6 to 12 months, and every 4 weeks after 12 months of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
- DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder. (Comorbid depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia [CDSS]. A score of 7 or higher will be exclusionary.)
- History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine or caffeine dependence is acceptable.
- Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
- Has a score of 6 (severe) or higher in 2 or more of the following 4 core symptoms of piscosis: conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content (derived from PANSS).
- Severity of psicosis is rated severe or higher (CGI-S of 7).
- History or current diagnosis of other psychiatric disorders (Axis I diagnosis) or behavioral disorders that could interfere with the conduct or interpretation of the trial.
- Known suicidal risk. Patients who have exhibited suicidal behavior within the past 6 months, as indicated by an actual attempt, interrupted attempt, aborted attempt, or preparatory acts will be excluded from participating in the trial. In making the assessment of suicidal risk, the Investigator should take into account the ratings on the C-SSRS (based on the past 1 month), with a ‘YES’ response on the Suicidal Ideation Item 4 or Item 5, or a ‘YES’ response on any of the five C-SSRS Suicidal Behavior items being exclusionary.
- Treatment resistant” defined significant persistent symptoms of schizophrenia after adequate doses of two standard antipsychotic medications (from two different chemical classes, including at least one atypical antipsychotic) following 6 weeks of treatment with each at adequate doses. Treatment resistant patients on clozapine for at least 6 months will be permitted if they have shown minimal improvement in the Investigator’s judgement.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method