Patients with psychiatric disorders who participated in a previous trial with evenamide. MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorde
Conditions
Interventions
Product Name: Evenamide
Product Code: [NW3509]
Pharmaceutical Form: Capsule, hard
Current Sponsor code: NW3509
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Conce
Sponsors
NEWRON PHARMACEUTICALS SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient completed the specified treatment period in their prior evenamide study -Patient has provided informed consent for this extension study - If female, the patient must have a negative pregnancy test at baseline and must not be lactating (If of childbearing potential, the patient agrees to continue using 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 until the final follow-up visit. A woman is considered to be of non-childbearing potential if she meets one of the following criteria: is post-menopausal has no uterus, ovaries or fallopian tubes. Women who are taking hormone replacement therapy (HRT) must use contraception (as described above) during the trial. Sexual abstinence is not an acceptable method of contraception. -Male patients 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 patients 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. 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patient demonstrated substantial non-compliance with any requirement of the protocol in the prior study, as judged by the Investigator, that would put him/her at risk for continuing treatment in Study 020; 2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during the prior study; 3. Patient is experiencing any moderate/severe neurological adverse events; 4. Patient has shown significant worsening of symptoms of his/her psychiatric disorder between baseline and the final assessment during the treatment period in the prior study; 5. Patient demonstrated substantial non-compliance with dosing of the study medication or the concomitant psychotropic medication in the prior study, as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of evenamide (15 and 30 mg bid) in patients with psychiatric disorders. Disease-Specific Efficacy Objectives: Schizophrenia: • Primary: To evaluate the long-term efficacy of evenamide (15 and 30 mg bid), based on improvement in symptoms of psychosis, as assessed by the change from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the total score on the Positive and Negative Syndrome Scale (PANSS). Bipolar Disorder: • Primary: To evaluate the long-term efficacy of evenamide (15 and 30 mg bid), based on improvement in symptoms of mania, as assessed by the change from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the total score on the Young Mania Rating Scale (YMRS).;Secondary Objective: Other Secondary Efficacy Objectives (all patients): • To determine the long-term effect of evenamide on general functioning, based on the change from baseline to endpoint (Week 52 or early discontinuation) on the Global Assessment of Functioning (GAF) scale. • To determine the long-term effect of evenamide on daily functioning, based on the change from baseline to endpoint (Week 52 or early discontinuation) on the Strauss-Carpenter Levels of Functioning (LOF) scale. • To evaluate the patients’ satisfaction with the study medication, compared to their previous treatment, using the Patient’s Medication Satisfaction Questionnaire (MSQ).;Primary end point(s): Primary efficacy endpoint. Mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the PANSS total score (schizophrenia patients) or YMRS (bipolar disorder patients) will be presented.;Timepoint(s) of evaluation of this end point: Week 52 or early discontinuation. A similar assessment of safety data will be performed by the ISMB in each additional one-year segment of the study if treatment is to be extended for another year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints. For bipolar disorder patients, mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the PANSS total score and MADRS total score will be presented. The mean score at each visit and at endpoint for the CGI-C (schizophrenia patients) or CGI-BP-C (bipolar disorder patients) will be presented. The distribution of patients by each category of change and the proportion of patients with improvement, no change, or worsening from baseline to endpoint on the CGI-C or CGI-BP-C will be provided. Mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the CGI-S (schizophrenia patients), CGI-BP-S (bipolar disorder patients), GAF, LOF and MSQ will be presented.;Timepoint(s) of evaluation of this end point: Week 52 or early discontinuation. A similar assessment of safety data will be performed by the ISMB in each additional one-year segment of the study if treatment is to be extended for another year. | — |
Countries
Argentina, Croatia, Germany, Hungary, India, Italy, Mexico, Poland, Romania, United Kingdom
Contacts
Public ContactClinical Operations’ Coordinator
Hippocrates Research Srl
Outcome results
None listed