EUCTR2015-001549-96-PL进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM USE OF LACOSAMIDE (FLEXIBLE DOSE FROM 200 TO 600 MG/DAY) USED AS MONOTHERAPY IN SUBJECTS WHO COMPLETED SP0994 AND RECEIVED LACOSAMIDE MONOTHERAPY TREATMENT
CB BioPharma SPR0 个研究点目标入组 150 人开始时间: 2015年11月20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
- 150
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
- •1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
- •2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator.
- •3. Subject has completed the Termination Visit of SP0994 and has been treated with Lacosamide monotherapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 134
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide.
- •2. Subject experienced a seizure at the third target dose (ie, Lacosamide 600 mg/day) during SP0994.
- •3. Subject requires another antiepileptic drug for the treatment of seizures.
- •4. Subject meets a must” withdrawal criterion for the previous study, SP0994.
- •5. Subject is experiencing an ongoing serious adverse event from the previous study, SP0994.
- •6. Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study.
研究者
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