A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome

Eisai Co, Ltd.0 个研究点目标入组 54 人开始时间: 2017年2月23日最近更新: 2017年3月13日

试验速览

暂无简介。

•1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
•2. Male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures.
•3. Participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 study.
•4. Participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 54
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
•2. Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
•3. Participants who were judged by the investigator that they were unfit to participate in this clinical trial.

发起方

Eisai Co, Ltd.