EUCTR2014-003330-12-IT进行中（未招募）1 期
A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy - A study of UCB0942 in adult patients with highly drug-resistant focal epilepsy
CB Biopharma SR0 个研究点目标入组 55 人开始时间: 2021年1月20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
- 55
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
- •·Subject is an adult (18 years of age or more).
- •·Subject is able to understand the study and the ICF as assessed by the Investigator. Subjects with known mental retardation (defined as IQ below 70) are not eligible to participate.
- •·A written ICF approved by the or Independent Ethics Committee (IEC) 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. A separate ICF should be signed and dated by the subject to allow for the optional DNA, mRNA, and lipidomics/proteomics/additional blood biomarker samples.
- •·Subject and/or caregiver is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and the medication intake scheme as instructed according to the judgment of the Investigator.
- •·Subject is of normal weight as determined by a body mass index (BMI) between 16.0 and 40.0kg/m2 (exclusive) and with a body weight of at
- •least 50kg (males) or 45kg (females).
- •·Subject fulfills ILAE (1989) criteria for focal epilepsy: - clinical semiology should be described and fulfill criteria for focal seizures.
- •- there will have been an electroencephalogram (EEG) reading compatible with focal epilepsy in the last 5 years.
- •- the subject has no seizures that are not focal by the new ILAE criteria.
- •- a brain MRI (magnetic resonance imaging) or head CT (computed tomography) to be performed before randomization, if no such scan was performed in the last 5 years, and a report is available. If a scan was
- •performed within the last 5 years but the epilepsy has not been stable since the last scan, a new scan should be obtained.
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •·Subject has past or present substance abiuse/dependence that in the opinion of the investiagator could threaten the subject's safety within the study,affect the subject's ability to fully participate in the study,or confound study interpretation.·Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device).·Subject has either:>1.5x 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).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 randomized 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 Case Report form (CRF).If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at
- •screening, 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.·Subject has a known hypersensitivity to any components of UCB0942 formulation or to similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy that, in the opinion of the Investigator or
- •UCB Study Physician, contraindicates her/his participation.·Subject has had significant blood loss or has donated or received 1 or more units (450mL) of blood within 30 days prior to UCB0942 administration, or has donated plasma or platelets within 14 days prior to UCB0942 administration for this study.·Subject tests positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg), or hepatitis C
- •antibody (HCV-Ab).
研究者
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