2025-522872-10-00招募中3 期
A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 28
- 主要终点
- Severity and frequency of TEAEs, SAEs, AESIs and ECIs
研究概览
简要总结
To assess the safety and tolerability of long-term treatment with 20 mg azetukalner once daily in participants with bipolar depression.
研究设计
- 分配方式
- Na
- 主要目的
- Entire trial period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression
- •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 protocol contraception requirements, as defined in the protocol.
排除标准
- •Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
- •Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
- •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.
- •Female participant who is pregnant, breastfeeding, or planning to become pregnant.
- •Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study.
- •Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.
- •Participant has had an active suicidal plan/intent (answer “yes” on item 4 or 5 in the C-SSRS Suicidal Ideation section) since the last visit, and/or based on the clinical assessment of suicidality risk by the investigator.
研究组 & 干预措施
XPF-010
Test
干预措施: XPF-010 (Drug)
结局指标
主要结局
Severity and frequency of TEAEs, SAEs, AESIs and ECIs
Severity and frequency of TEAEs, SAEs, AESIs and ECIs
次要结局
- Change from baseline in the MADRS total score over time.
- Change in CGI-S score over time.
- Change from baseline in the SHAPS total score over time.
研究者
Clinical Trial responsible person: Vice President Psychiatry Clinical Development
Scientific
Xenon Pharmaceuticals Inc.
研究点 (28)
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