2025-523618-10-00招募中3 期
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 22
研究概览
简要总结
To assess the safety and tolerability of long‑term treatment with azetukalner in participants with MDD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant successfully completed the treatment period of an antecedent Phase 3 study evaluating azetukalner in participants with MDD.
- •Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
- •Participant is willing to comply with the contraception requirements
- •Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
排除标准
- •Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- •Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- •Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- •Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
- •Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
- •Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
- •Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug
研究组 & 干预措施
XPF-010
Test
干预措施: XPF-010 (Drug)
研究者
Xenon Medical Affairs
Scientific
Xenon Pharmaceuticals Inc.
研究点 (22)
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