NL-OMON50315已完成2 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 Adult Subjects With Highly Drug-Resistant Focal Epilepsy - UCB0942 Open-Label Extension Study (EP0073)
CB Biopharma SR0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
- •acceptabletolerability according to the subject and Investigator.
- •- 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).
排除标准
- •- Subject has developed a known hypersensitivity to any components of the
- •investigational medicinal product (IMP) as stated in this protocol during
- •participation in EP0069.
- •- Subject has any severe medical, neurological, or psychiatric condition, or
- •laboratory value which may have an impact on the safety of the subject.
- •- Subject is a woman who is pregnant or lactating.
- •- 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 C-SSRS. The subject should be referred immediately to a Mental Healthcare
- •Professional and must be withdrawn from the study.
- •- Subject has taken other (non-AED) 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 ECG 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 >450ms for males
- •and >470ms for females
- •* Bundle branch blocks and other conduction abnormalities other than mild first
- •degree atrioventricular block (defined as PR interval *220ms)
- •* 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
- •EV (V2) of EP0073.
- •- Subject has >2x upper limit of normal (ULN) of any of the following: alanine
- •aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase
- •(ALP), or >ULN total bilirubin (*1.5xULN total bilirubin if known Gilbert*s
- •syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations
- •only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to
- •identify possible undiagnosed Gilbert*s syndrome (ie, direct bilirubin <35%).
- •- For enrolled subjects with a baseline result >ULN for ALT, AST, ALP, or total
- •bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful
- •elevation must be understood and recorded in the electronic Case Report form
- •If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at
- •screening (ie, the value is >ULN but *2xULN at the EV [V2] of EP0073), repeat
- •the tests, if possible, prior to dosing to ensure there is no further ongoing
- •clinically relevant increase. In case of a clinically relevant increase,
- •inclusion of the subject must be discussed with the Medical Monitor.
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