A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy (X-TOLE4) - XPF-010-304

Xenon Pharmaceuticals Inc.0 个研究点目标入组 994 人开始时间: 2023年6月16日最近更新: 2024年8月21日

研究概览

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•Subject must have successfully completed the Double bling period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject’s entry into the long-term extension study., Subject is able to keep accurate seizure diaries., Subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study., Subject must be willing to comply with the contraception requirements as defined in protocol Section 5.3., Male subjects must agree not to donate sperm until 3 months after the last dose of study drug. Female subjects must agree not to donate ova until 6 months after the last dose of study drug., In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.

•Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT, Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol., Female subject who is pregnant, breastfeeding, or planning to become pregnant prior to 6 months after the last dose of study drug., Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.

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