A Phase II/III, multi-center, open-label, extension study to determine the long-term safety, tolerability, and efficacy of evenamide in patients with psychiatric disorders who participated in a previous trial with evenamide. - Evenamide_020

EWRON PHARMACEUTICALS SPA0 个研究点目标入组 500 人开始时间: 2021年8月31日最近更新: 2022年3月2日

研究概览

暂无简介。

•- 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

•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.

发起方

EWRON PHARMACEUTICALS SPA