EUCTR2018-002981-37-BG进行中（未招募）1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •In addition to satisfying all the inclusion criterion established in YKP3089C025, each subject must meet the following inclusion criteria to be enrolled in the study:
- •The subject must have successfully completed the Double-blind Treatment Period in the Core study.
- •Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in
- •accordance with ICH guidelines
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •In addition to all the exclusion criterion established in YKP3089C025, subjects meeting any of the following criteria will be excluded from
- •Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
- •Any significant changes to the subject’s medical history that, in the opinion of the Principal Investigator, could affect the subject’s safety or conduct of the study.
- •Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor.
研究者
相似试验
进行中（未招募）
1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic SeizuresPrimary Generalized Tonic-Clonic SeizuresMedDRA version: 20.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 100000004852EUCTR2018-002981-37-CZSK Life Science, Inc.130
进行中（未招募）
1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic SeizuresEUCTR2018-002981-37-DESK Life Science, Inc.145
进行中（未招募）
1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic SeizuresPrimary Generalized Tonic-Clonic SeizuresMedDRA version: 20.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 100000004852EUCTR2018-002981-37-PLSK Life Science, Inc.145
招募中
1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic SeizuresPrimary Generalized Tonic-Clonic SeizuresMedDRA version: 26.1Level: PTClassification code: 10018100Term: Generalised tonic-clonic seizure Class: 100000004852CTIS2023-506688-32-00Sk Life Science Inc.131
进行中（未招募）
1 期
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic SeizuresPrimary Generalized Tonic-Clonic SeizuresMedDRA version: 20.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 100000004852EUCTR2018-002981-37-SKSK Life Science, Inc.145