An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication.

ewron Pharmaceuticals SpA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•Patients must meet the following inclusion criteria to be eligible for enrollment into the study:
•1. Patient completed 6 weeks of treatment in Study 014.
•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).

•The presence of any of the following will exclude a patient from study enrollment:
•1. Patient violated any requirement of the protocol in Study 014 that would put him/her at risk for continuing treatment with evenamide in Study 015.
•2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during Study 014.
•3. Patient is experiencing any moderate/severe neurological side effects, other than pre-existing EPS related to antipsychotic treatment prior to enrolling in Study 014.
•4. Patient has shown significant worsening of his/her symptoms of schizophrenia between baseline and the final assessment during the 6-week treatment period in Study 014, such that continuing treatment in Study 015 is considered undesirable.
•5. Patient demonstrated substantial non-compliance with dosing of the study medication in Study 014.

发起方

ewron Pharmaceuticals SpA