A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY
概览
- 阶段
- 3 期
- 干预措施
- Brivaracetam Film-coated tablet
- 疾病 / 适应症
- 未指定
- 发起方
- UCB Biopharma SRL
- 入组人数
- 120
- 试验地点
- 34
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) during the study
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
研究者
入排标准
入选标准
- •Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
- •Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
- •Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
- •\- Capable of and provides informed consent/assent, and the participant's parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol
排除标准
- •Participant has a history or presence of paroxysmal nonepileptic seizures
- •Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
- •Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
- •Participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (for participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately to a Mental Healthcare Professional
- •Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
- •Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure
- •Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- •Participant is receiving any investigational drugs or using any experimental devices in addition to BRV
- •Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)
- •Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator
研究组 & 干预措施
Brivaracetam arm
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
干预措施: Brivaracetam Film-coated tablet
Brivaracetam arm
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
干预措施: Brivaracetam oral solution
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) during the study
时间窗: From Entry Visit up to the Safety Visit (up to 3 years)
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
时间窗: From Entry Visit up to the Safety Visit (up to 3 years)
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
次要结局
- Incidence of serious adverse events (SAEs) during the study(From Entry Visit up to the Safety Visit (up to 3 years))
- Incidence of IMP related TEAEs during the study(From Entry Visit up to the Safety Visit (up to 3 years))