EUCTR2004-000200-40-HU进行中（未招募）1 期
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy OfLevetiracetam In Children With Partial Onset Seizures. - Pediatric Exclusivity Long-term Follow-up
CB S.A.0 个研究点目标入组 255 人开始时间: 2006年3月29日最近更新:
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
- 255
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
- •Before any study procedures are initiated for any patient in this study, an IRB/IEC approved written informed consent form will be properly executed and documented.
- •To be eligible to participate in this study, the following criteria must be met:
- •Patients parent(s)/legally authorized representative(s) must have consented to participate in a previous levetiracetam pediatric trial (N01009 or N01103). The last visit of the previous levetiracetam study should occur on the same day as the 1st visit of this study.
- •Patients having been screened, but not eligible for one of the 2 above mentioned studies, may be considered to enter this study. Visit 1 will occur on the same day as the screen failure.
- •The patients parent(s)/legally authorized representative(s) must give consent and sign and date the IRB/IEC approved written informed consent form for N01148, if applicable, the patient will sign an assent.
- •Patient must have epilepsy with partial onset seizures.
- •Be a patient for whom the treatment of levetiracetam would be of potential benefit.
- •Be a male, or a non-pregnant, non-nursing female. Females of childbearing potential must be using a medically acceptable method of contraception or must agree to abstain from sexual contact. Abstinence must be discussed with UCB or designee on a case by case basis. Females of childbearing potential will have pregnancy tests performed at each scheduled visit during the course of the study.
- •If the patient was a screen failure in the previous study, the patient
- •must be between 1 month and 16 years of age, inclusive.
- •Patient may have Vagus Nerve Stimulation (VNS), the settings should
- •be stabilized for at least 2 months prior to Visit 1. Activated VNS must
- •be counted as one of the two AEDs.
- •Patient must be on a stable regimen of one or a maximum of two other
- •If the patient was a screen failure in the previous study, the patient
- •must have had at least 2 partial onset seizures during the four weeks
- •prior to Visit 1.
- •Patient and/or their parent(s)/legally authorized representative(s) must
- •be able to cooperate with the Investigator and study personnel involved
- •in carrying out the study.
- •If enrolling from N01103, the patient must have an Intelligence Quotient (IQ) of at least 70 as assessed during N01103 or at Visit 1 of N01148.
- •If enrolling from N01103, the patient and patient's parent(s) or legally authorized
- •representative(s) must be fluent in English.
- •If enrolling from N01103 and if epilepsy surgery has been performed,
- •then the patient should have a documented failed epilepsy surgery
- •outcome of greater than 6 months prior to Visit 1.
- •If enrolling from N01009 and if epilepsy surgery has been performed,
- •then the patient should have a documented failed epilepsy surgery
- •outcome of at least 4 weeks prior to Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must be excluded if they meet any of the following criteria:
- •Participating in any other clinical trial of another investigational drug or device during this study.
- •Have a history of poor compliance with visit schedule or medication intake.
- •Are on a ketogenic diet (during the course of this study).
- •Have seizures too close together to accurately count (i.e., the patient?s seizures must be countable).
- •Have clinically significant deviations from reference range values for laboratory
- •parameters as determined by the investigator on the blood sample of the last visit of the previous study.
- •Have any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the investigator) such as, but not limited to: cardiac disease, liver disease, renal disease, or psychiatric illness.
- •Patient has a treatable seizure etiology other than epilepsy (i.e., febrile seizures).
- •Patient has a history of status epilepticus, which required hospitalization during one month prior to Visit 1, except for status epilepticus occurring during the first 10 days of life.
- •Patient has a current diagnosis of Lennox-Gastaut Syndrome.
- •Patient has epilepsy secondary to a progressing cerebral disease or any other
- •progressively neurodegenerative disease, such as Rasmussen and Landau-Kleffner
- •Patient has a history of an allergy to pyrrolidine derivatives or a
- •history of multiple drug allergies.
- •Patient is known to have a terminal illness.
- •Patient has any disorder or condition that may interfere with the
- •absorption, distribution, metabolism, or excretion of medications.
- •Patient has a history of or presence of pseudoseizures.
- •Patient has any medical condition that might interfere with the
- •subject™s study participation (i.e., serious infection, scheduled elective
- •surgery, etc).
- •Patient enrolling from N01103 has a current psychiatric diagnosis of
- •severe Attention Deficit Hyperactivity Disorder (ADHD), severe
- •behavior disorder or severe learning disorder.
- •Patient enrolling from N01103 receiving phenobarbital or primidone
- •on a routine or chronic basis.
研究者
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