Chronic schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Evenamide
Product Code: NW3509
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Evenamide
Current Sponsor code: NW3509
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Newron Pharmaceuticals S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. [see Exclusion criteria] - Has been treated with antipsychotics for at least 2 years. - Has a total score on the PANSS >70 and =85. - 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. 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - 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. - Severity of psychosis is rated severe or higher (CGI-S of 7). - Known suicidal risk. Patients who have exhibited suicidal behaviour 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the safety and tolerability (including EEG and ECG effects) of an oral dose of evenamide of 30 mg bid [60 mg/day]), achieved after a 1-week titration starting with 15 mg bid, compared to placebo, in patients with schizophrenia who are being treated with stable doses of antipsychotic medication (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone) -To evaluate the efficacy of evenamide at a dose of 30 mg bid, achieved after a 1-week titration starting with 15 mg bid, compared to placebo, based on improvements in symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) total score.;Secondary Objective: -To evaluate the efficacy of evenamide at a dose of 30 mg bid, achieved after a 1-week titration starting with 15 mg bid, compared to placebo, based on improvements in symptoms of schizophrenia, as assessed by the CGI - Change from baseline (CGI-C); and as assessed by the Clinical Global Impression - Severity of illness (CGI-S). -To determine the multiple-dose pharmacokinetics (PK) of evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid, at a dose of 30 mg bid; -To determine the effect of evenamide, compared to placebo, on daily functioning, based on improvements on the Strauss-Carpenter Level of Functioning (LOF) scale; -To determine the patient’s satisfaction with treatment, compared to their previous treatment, based on improvements on the Medication Satisfaction Questionnaire (MSQ).;Primary end point(s): To evaluate the safety, tolerability, and evidence of efficacy of evenamide (30 mg bid) treatment in patients with chronic schizophrenia;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Argentina, Croatia, Czechia, Czech Republic, Estonia, Germany, Hungary, India, Italy, Latvia, Mexico, Poland, Romania, Spain, United Kingdom
Contacts
Public ContactRavi Anand
Newron Pharmaceuticals S.p.A.
Outcome results
None listed