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临床试验/EUCTR2004-000200-40-BE
EUCTR2004-000200-40-BE进行中（未招募）不适用

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. Pharma Sector0 个研究点目标入组 250 人开始时间: 2005年8月31日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
250
研究概览入排标准研究者记录与标识符相似试验

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

发起方
CB S.A. Pharma Sector

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