EUCTR2004-001997-13-AT进行中（未招募）不适用
An open-label, multicenter, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV) (oral tablets of 166, 250 or 500 mg b.i.d.), at individualized doses up to a maximum of 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg), in children (= 4 years old), adolescents and adults suffering from primary generalized seizures - PGS long-term follow-up
CB S.A. Pharma Sector0 个研究点目标入组 300 人开始时间: 2004年10月18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
- 300
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
- •Written informed consent, dated and signed by the subject or, when needed, by (preferably both) parents or legal guardian (not applicable at the study site in Innsbruck).
- •Male or female children, adolescents and adults having completed the final visit of the double-blind study N166, the final visit of the double-blind study N01057, the second-year evaluation visit of the open follow-up study N164 or the final visit of the open follow-up study N129 (at the study site in Innsbruck only adults will be included).
- •The final visit of the previous study and entry into the present study will ideally occur on the same day.
- •Subjects who were/are suffering from primary generalized (type II) epileptic seizures, according to the Guidelines of the International League Against Epilepsy (ILAE). (6.)
- •Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected.
- •Female subjects must be premenarcheal, two years postmenopausal or surgically sterile (bilateral oophorectomy or tubal ligation, complete hysterectomy) or using a medically accepted contraceptive method (intrauterine device, barrier method plus spermicide, oral contraceptive at a stable dose for one menstrual cycle prior to the start of the study, contraceptive implant inserted at least one month prior to the start of the study, or contraception injection administered one month prior to the start of the study). Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion with UCB Pharma or its representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.
- •Subjects must be considered as reliable and capable of adhering to the protocol, according to the judgement of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Pregnant, lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- •Known allergy to, or intolerance of, pyrrolidine derivatives or the other excipients of levetiracetam tablets (principally, but not exclusively, lactose, corn starch and cellulose).
- •Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
- •Clinically significant deviations from reference range values for laboratory parameters, as determined by the Investigator.
- •Receipt of any drug with possible central nervous system effects unless at a stable dose.
- •Receipt of any drug (other than hormonal treatment and the subject.s normal AED(s)) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time.
- •History in prior levetiracetam study of poor compliance with visit schedule or medication intake.
- •Known alcohol or drug addiction or abuse within the past two years.
- •Participation in any clinical trial of another investigational drug or device during the study.
研究者
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