Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: NW-3509: Fixed doses of 15 mg bid and 30 mg bid of evenamide
Control Intervention1: Placebo: Fixed doses of 15 mg bid and 30 mg bid of matching placebo
Sponsors
Newron Pharmaceuticals SpA
CliniRx Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient must meet the following inclusion criteria to be eligible for enrollment into the study Demographics 1 Age 18 years, or older, at screening. The suitability of elderly patients example less than 80 years of age for enrolment in the study should be discussed with the Medical Monitor. 2 If female, the subject has a negative pregnancy test at the screening visit and at baseline, and is not lactating. 3 If female and of childbearing potential, the subject agrees to use adequate contraception, as determined by her Health Care Provider or according to local guidelines Contraception Requirements for Women of Childbearing Potential Enrolled at Sites in the European Union are provided in Appendix 6 Sexual abstinence is not an acceptable method of contraception. 4 A woman is considered to not be of childbearing potential if she meets one of the following criteria a is post menopausal the last menstrual period was at least 12 months ago, and FSH at screening confirms post menopausal status, b has had a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy Women who are taking hormone replacement therapy must use adequate contraception during the trial 5 Body mass index of at least 17.5 and less than 35. Patients with a BMI of less than 17.5, or 35 or higher may be considered for enrollment on a case by case basis if, in the Investigators opinion, this does not put the patient at any additional risk for participating in the trial. These cases should be discussed with the Medical Monitor and documented in the source records Psychiatric 6 Currently meets DSM 5 TR diagnostic criteria for schizophrenia, as confirmed by the Mini International Neuropsychiatric Interview for Psychotic Disorders Studies 7.0.2. Other psychiatric disorders may be present as lifetime diagnoses if the current episode of schizophrenia is confirmed by the principal investigator 7 Confirmation of treatment resistance, according to the consensus guidelines from the Treatment Response and Resistance in Psychosis working group, by documentation in the medical records that the patient has had no, or inadequate symptomatic relief to at least two antipsychotics, including one second generation antipsychotic, despite treatment for at least 6 weeks at adequate doses as specified in the product label 8 Requires antipsychotic treatment and is currently receiving standard of care, consisting of one or more oral given for at least 6 weeks prior to screening or depot given for at least 2 cycles antipsychotic at a stable therapeutic dose, in accordance with the package insert. Only second generation antipsychotics listed in Appendix 5 will be permitted as the primary antipsychotic. Other second generation antipsychotics not on the list, as well as first generation antipsychotics, will be allowed as secondary antipsychotics. The patients current antipsychotics may be the same as one of the two antipsychotics the patient did not benefit from previously. If the minimum therapeutic dose of the primary antipsychotic is not tolerated, the maximum tolerated dose may be used a The plasma level of the concomitant primary antipsychotic measured at screening must be equivalent to or greater than the minimum plasma concentration that would correspond to a therapeutic dose of the drug based on the manufacturers recommendation a list of therapeutic plasma concentration ranges for the al
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a patient from study enrollment Psychiatric 1 Current DSM 5 TR diagnosis of schizophreniform disorder 295.40, schizoaffective disorder 295.70, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder 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 2 History within three months of study entry or current diagnosis of Substance Use Disorder as defined by the DSM 5 TR 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. Patients testing positive for THC on the urine drug screen will not be excluded from the study unless there is evidence of toxic psychosis 3 The patient is currently hospitalized to stabilize the severity of his or her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening. Patients who are chronically hospitalized and will remain so for the duration of the study, or in psychiatric daycare, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study 4 BPRS total score has improved by more than 20 percent from screening to baseline 5 CGI-S has improved by 1 point or more from screening to baseline 6 Has a CGI S rating of 7 among the most extremely ill patients 7 Has a history or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study 8 Has 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 9 Has a history of neuroleptic malignant syndrome or priapism. Medical Status 10 Has an advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may significantly bias the assessment of the clinical or mental status of the patient or put the patient at special risk example liver or kidney disease, severe uncontrolled asthma, malignancy 11 Has a disability that may prevent the subject from completing all study requirements example blindness, deafness, severe language difficulty 12 Has insulin dependent diabetes mellitus 13 Patients with non insulin dependent diabetes will be eligible if the following criteria are satisfied a HbA1c more than 7.0 percent at screening, b Diabetes is considered well controlled, with no changes in treatment regimen for at least 4 weeks prior to screening, c Diabetes is not newly diagnosed at screening 14 Has a history or current diagnosis of any neurodegenerative illness, dementia, significant concomitant ne
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean changes from baseline to endpoint Week 12 on the PANSS total score will be compared between the evenamide 30 mg bid and placebo groups using a mixed-effects repeated measures model approach (MMRM), with treatment, region, visit, and treatment-by-visit interaction as fixed effects, and baseline value as covariate, will be used to analyze the mean change from baseline to Week 12 on the PANSS Total Score. Timepoint: Primary efficacy timepoint of outcome is at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean change from baseline on the CGI S at endpoint Week 12 will be compared between the evenamide 30 mg bid dose & placebo groups using the same MMRM approach used for the primary efficacy endpoint, with treatment, region, visit, & treatment by visit interaction as fixed effects, & baseline value as covariateTimepoint: Secondary efficacy timepoint is at 12 weeks. | — |
Countries
Argentina, Bulgaria, Colombia, Croatia, Czech Republic, France, Germany, Hungary, India, Italy, Malaysia, Mexico, Poland, Portugal, Romania, Slovakia, Spain, Sri Lanka, United Kingdom
Contacts
Public ContactShiv Issar
CliniRx Research Pvt. Ltd.
Outcome results
None listed