Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 34
- 主要终点
- - Incidence and severity of treatment-emergent adverse events (TEAEs), including discontinuation of study drug due to TEAEs. - Changes in vital sign measurements. - Changes in clinical laboratory results. - Changes in electrocardiogram parameters. - Changes in suicidality, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
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 and caregiver (if applicable), is willing to sign an informed consent document in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, indicating that they understand the purpose of the clinical trial; understands and can perform, complete, and comply with all the procedures and assessments that are required during the clinical trial, including the seizure diary and contraception, and is willing to participate in the clinical trial.
- •Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trial, 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 listed in Table
- •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.
结局指标
主要结局
- Incidence and severity of treatment-emergent adverse events (TEAEs), including discontinuation of study drug due to TEAEs. - Changes in vital sign measurements. - Changes in clinical laboratory results. - Changes in electrocardiogram parameters. - Changes in suicidality, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
- Incidence and severity of treatment-emergent adverse events (TEAEs), including discontinuation of study drug due to TEAEs. - Changes in vital sign measurements. - Changes in clinical laboratory results. - Changes in electrocardiogram parameters. - Changes in suicidality, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
次要结局
- (EXPLORATORY) Percent change in monthly (28 days) focal or generalized seizure frequency from the Screening/Observation Period of the primary trial.
- (EXPLORATORY) Changes in Patient Global Impression of Severity (PGI-S) and Clinical Global Impression of Severity (CGI-S).
- (EXPLORATORY) Vormatrigine plasma concentrations
研究者
Kate Sheffey
Scientific
Praxis Precision Medicines Inc.