A long-term clinical study using Evenamide (orally taken new drug without masking its strength) to determine its safety, tolerability and efficacy in patients with treatment resistant schizophrenia, not befitting adequately from their current antipsychotic medicatio
Phase 2
- Conditions
- Schizophrenia
- Registration Number
- SLCTR/2020/024
- Lead Sponsor
- Dr Ravi Anand/Newron Pharmaceuticals S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Patient completed 6 weeks of treatment in Study NW-3509/014/II/2019
2. Patient has provided written informed consent for this extension study.
3. If female, patient is not of childbearing potential, pregnant or breastfeeding.
For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with adequate contraception (barrier method or hormonal contraceptive).
Exclusion Criteria
1) Protocol violation during 014 study.
2) Worsening of suicidal risk during 014 study
3) Moderate/severe neurological side effects during 014 study
4) Worsening of schizophrenia symptoms during study 014
5) Non compliance with dosing of study medication during 014
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method