EUCTR2006-006346-34-CZ进行中（未招募）不适用
An international, randomized, double-blind, parallel-group, placebo-controlled, flexible dose study: evaluation of the safety and efficacy of brivaracetam in subjects (>=16 to 70 years old) suffering from localization-related or generalized epilepsy.
CB Pharma S.A.0 个研究点目标入组 588 人开始时间: 2007年4月3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
- 588
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
- •Subjects from 16 to 70 years, both inclusive. Subjects under 18 years may only be
- •included where legally permitted and ethically accepted.
- •Subjects with well-characterized localization-related epilepsy or generalized epilepsy according to the ILAE classification (1).
- •For subjects suffering from:
- •localization-related epilepsy (1): subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1 according to ILAE classification (2).
- •generalized epilepsy (1): subjects having at least 2 Type II seizure days per month during the 3 months preceding V1 according to the ILAE classification (2).
- •For subjects suffering from:
- •localization-related epilepsy (1): subjects having at least 4 partial onset seizures whether or not secondarily generalized during the 4-week Baseline Period
- •according to the ILAE classification (2).
- •generalized epilepsy (1): subjects having at least 4 Type II seizure days during the 4-week Baseline Period according to the ILAE classification (2).
- •Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AED(s).
- •Vagal Nerve Stimulation (VNS) is allowed and will not be counted as a concomitant
- •Permitted concomitant AED(s) and VNS (implanted for at least 9 months) being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital and primidone) before V1 and expected to be kept stable during the Treatment Period. Benzodiazepine (BZD) taken more than once a week (for any indication) will be considered as a concomitant AED.
- •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
- •Subjects suffering from epilepsies and syndromes undetermined whether focal or
- •generalized (classification 3 according to the ILAE classification (1)).
- •Subjects suffering from special syndromes (classification 4 according to the ILAE
- •classification (1)).
- •For subjects suffering from localization-related epilepsy (1): history or presence of
- •seizures occurring only in clusters (too frequently or indistinctly separated to be
- •reliably counted) before V2 or occurring only as type 1A non-motor.
- •History or presence of status epilepticus during the year preceding V1 or during
- •History or presence of known pseudo-seizures.
- •Subjects taking any drug with possible CNS effects except if stable from at least 1
- •month before V1 and expected to be kept stable during the Treatment Period.
- •Subjects taking any drug that may significantly influence the metabolism of BRV
- •(CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable
- •at least 1 month before V1, and is expected to be kept stable during the Treatment
- •History of cerebrovascular accident (CVA), including transient ischemic attack (TIA),
- •within the last 6 months.
- •Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing
- •(i.e. not expected to stay stable during trial participation) brain disorder or brain tumor.
- •Stable arteriovenous malformations, meningiomas or other benign tumors may be
- •acceptable.
研究者
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