NCT07287163Enrolling By Invitation3 期
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
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
- 700
- 试验地点
- 37
- 主要终点
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
研究概览
简要总结
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
详细描述
An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program)
- •Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor
排除标准
- •Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor
- •Participant who plans to enter another interventional investigational study or is on any prohibited medication
- •Participant who is pregnant, lactating or planning to become pregnant
- •Participant who is ineligible for the extension clinical trial in the view of the investigator
研究组 & 干预措施
Open-label 30 mg/day vormatrogine for up to 2 years
Experimental
Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.
干预措施: vormatrogine (Drug)
结局指标
主要结局
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
时间窗: Up to 2 years
Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
次要结局
未报告次要终点
研究者
研究点 (37)
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