EUCTR2015-001268-20-IT进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF UCB0942 WHEN USED AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES IN ADULTSUBJECTS WITH HIGHLY DRUG-RESISTANT FOCAL EPILEPSY - An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy
CB Biopharma SR0 个研究点目标入组 30 人开始时间: 2020年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
- •Subject must have completed V13 of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
- •In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
- •In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
- •No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
- •Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods.
- •Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) AND that the respective partner will use an additional contraceptive method
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Subject has active suicidal ideation as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the Since Last Visit” version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
- •Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
- •Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
- •- Prolonged QTc (Bazett’s, machine-read) interval defined as > 450 ms for males and > 470 ms for females
- •- Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval = 220 ms)
- •- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
- •- In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
- •Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073
研究者
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