EUCTR2011-005177-23-IT进行中（未招募）不适用
An open-label, multicenter, single-arm study to evaluate the reduction in nonpsychotic behavioral side effects in subjects with epilepsy switching from levetiracetam to brivaracetam due to nonpsychotic behavioral side effects
CB PHARMA SA/NV.0 个研究点目标入组 110 人开始时间: 2012年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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 male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted.
- •- Subject has a family member/caregiver or close contact person who is knowledgeable on a daily basis regarding the subject’s side effects. This family member/caregiver or close contact person should accompany the subject to the study visits or be available for discussion by telephone.
- •- Subject with well-characterized epilepsy according to the 1989 ILAE classification
- •- Subject with epilepsy who the Investigator expects would have benefitted from LEV but for whom the Investigator has decided to discontinue LEV due to nonpsychotic behavioral side effects following the introduction of LEV.
- •- Subject is currently receiving LEV at a dose between 1g/day and 3g/day and currently treated with 2 to 3 AEDs, including LEV.
- •- Permitted concomitant AED(s) (with the exception of LEV) and VNS are stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before V1 and are expected to be kept stable during the Screening and Treatment Periods.
- •- Subject with a body weight =40kg.
- •- Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 106
- •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 previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study-Subject has participated in another study of an investigational medication (or a medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device)-Subject has a history of chronic alcohol or drug abuse within the last year-Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study-Subject has a lifetime history of suicide attempt (including an active, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months. -Subject has a known hypersensitivity to any components of the (IMP) or comparative drugs as stated in this protocol-Subject has history of severe adverse hematologic reaction to any drug-Subject has been receiving LEV at any dose for more than 12 weeks prior to V1-Subject taking any drug that may significantly influence the metabolism of BRV, such as cytochrome P450 potent inducers, except if the dose has been kept stable at least 1 month before V1, and is expected to be kept stable during the Treatment Period-Subject on felbamate with less than 18 months exposure before V1-Subject not able to understand the Informed Consent form, Assent form, or daily record card -Subject has obvious cognitive impairment or mental retardation as per Investigator assessment-Subject whose seizures cannot be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)-Subject has history or presence of status epilepticus during the year preceding V1 or during the Screening Period-Subject has history or presence of known psychogenic nonepileptic seizures-Subject has presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor. -Subject has any clinical conditions that impair reliable participation in the study or necessitate the use of medication not allowed by protocol-Subject is suffering from severe cardiovascular disease or peripheral vascular disease-Subject has presence of a terminal illness-subject has presence of a serious infection-Subject has impaired hepatic function: ALT/SGPT (), AST/SGOT (), or alkaline phosphatase of more than 2 times the upper limit of the reference range-Subject has (GGT) values of more than 3 times the upper limit of the reference range. A result of GGT exceeding 3 times the upper limit can be accepted only if attributable to hepatic enzyme induction caused by concomitant antiepileptic treatment -Subject has clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated <30mL/min, platelets <100,000/µL, or neutrophil cells <1,800/µL-Subject is pregnant or lactating-Subjects are Investigators, co-Investigators, their spouses or children, or any study collaborators.
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