NCT07217860Enrolling By Invitation3 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
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 27
- 主要终点
- Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
研究概览
简要总结
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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 contraception requirements.
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.
- •Participant 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.
研究组 & 干预措施
Azetukalner 20 mg
Experimental
干预措施: Azetukalner (Drug)
结局指标
主要结局
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
时间窗: From the start of treatment in the open-label extension study through 8 weeks after the last dose
次要结局
- Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time(From baseline through the active extension treatment (Week 52))
- Change in Clinical Global Impression of Severity (CGI-S) score over time(From baseline through the active extension treatment (Week 52))
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time(From baseline through the active extension treatment (Week 52))
研究者
研究点 (27)
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