EUCTR2007-000897-21-PL进行中（未招募）1 期
A multi-center, double-blind, historical control, randomized conversion to monotherapy study with Keppra XR for treatment of partial onset seizures
CB, Inc.0 个研究点目标入组 223 人开始时间: 2007年10月31日最近更新:
适应症
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
- 223
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
- •Male or female subjects 12 to 75 years of age
- •Signed and dated written informed consent. Signed and dated written assent, if applicable.
- •Subjects must have inadequately controlled partial onset epilepsy with observable partial seizures that may be classified as simple complex or partial seizures evolving to secondary generalized seizures according to ILAE classification
- •Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on at least one, but no more than two standard AEDs, and auras are not being included in the seizure count.
- •Subjects must be on a stable dose for at least four weeks before Screening (Visit 1) of at least one, but no more than two other concomintant antiepileptic drugs (AEDs)
- •If taking two AEDs, one of the baseline AEDs should be taken at less than or equal to 50% of the minimum recommended dose
- •EEG must be consistent with localization related epilepsy
- •Previous CT scan or MRI confirming the subject is free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease
- •Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. The subjects must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive method, and undertake to inform the Investigator of any potential change in status.
- •Subjects must be capable of understanding and completing diaries and adhering to the protocol
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females who are lactating or pregnant
- •A history of status epilepticus in the 6 months preceeding randomization
- •Seizures that are uncountable due to clustering during the 8-week period prior to Screening (Visit 1) and during the 8-week Baseline Period
- •Significant medical, psychiatric or neurological illness
- •Benzodiazepine use
- •Suspected substance or alcohol abuse within 12 months preceding randomization
- •Use of any medication (other than concomitant AEDs) that influences the central nervous system (CNS) unless on a stable regimen for at least 4 weeks prior to Screening
- •History of previous treatment with levetiracetam or sensitivity to levetiracetam
- •Use of an investigational drug or device in the 4 months preceding randomization
- •Subjects may not enter the study if they are presently receiving phenobarbital, mysoline, or felbamate, or have an activated VNS device
- •Neuroleptics and traditional herbal AEDs are not allowed
- •History of recurrent psychotic or major affective disorder or suicide attempts
- •History or presence of pseudoseizures
- •Subjects on ketogenic diet
- •Subjects with digestive problems that could impair the absorption of the Keppra XR formulation
- •History of poor compliance with visit schedule or medication intake
- •Subjects taking part in another clinical/pharmacological study in the 30 days prior to Screening (Visit 1)
- •Subjects with any medical or surgical condition that might interfere with the subject's study participation, i.e. scheduled elective surgery, etc.
研究者
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