EUCTR2020-003664-29-HU进行中（未招募）1 期
Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
CB Biopharma SR0 个研究点目标入组 100 人开始时间: 2020年12月2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
- 100
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
- •Inclusion criteria for long-term follow-up (LTFU) study participants only:
- •- Study participants with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected;
- •Inclusion criteria for directly enrolled (DE) study participants only:
- •- Study participant is = 4 years to < 16 years of age;
- •- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years;
- •- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED);
- •- Study participant had at least 1 POS during the 4-week Screening Period;
- •- Study participant is taking at least 1 AED. Vagal nerve stimulator will be counted as a concomitant AED.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for all study participants:
- •- Study participant has, in the Investigator’s opinion, severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant;
- •- Study participant has any medical condition including chronic liver disease, which in the Investigator’s opinion, warrants exclusion;
- •- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). The use of antiepileptic drugs (AEDs) marketed for adults but not approved for pediatric use is not considered to be investigational” for the purposes of this study;
- •- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study;
- •Exclusion criteria for long-term follow-up (LTFU) study participants only:
- •- Study participant had poor compliance with the visit schedule or medication intake in the BRV core study;
- •- Study participant = 6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months
- •as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS);
- •Exclusion criteria for directly enrolled (DE) study participants only:
- •- Study participant has a history of primary generalized epilepsy;
- •- Study participant has a history of status epilepticus in the 30 days immediately prior to the Screening Visit (ScrV) or during the Screening Period;
- •- Study participant has history or presence of known psychogenic nonepileptic seizures;
- •- Study participant has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary;
- •- Study participant has any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator (eg, bone marrow suppression, chronic hepatic disease, severe renal impairment, psychiatric disorder as per Investigator assessment);
- •- Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator;
- •- Study participant has a clinically significant ECG abnormality according to the Investigator;
- •- Study participant had major surgery within 6 months prior to the ScrV.
研究者
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