EUCTR2020-001478-30-RO进行中（未招募）1 期
A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
CB Biopharma SR0 个研究点目标入组 100 人开始时间: 2022年5月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF)
- •- Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
- •- Participant is expected to benefit from participation, in the opinion of the Investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study
- •- Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
- •- Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- •- Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for EP0034 or SP848, or is experiencing an ongoing serious adverse event (SAE)
- •- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
研究者
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