NCT00887861已完成2 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Parallel-group Study of BGG492 as Monotherapy in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy
研究概览
简要总结
This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of partial seizures (with or without secondary generalization) and undergoing an evaluation for epilepsy surgery, based on the classification of the International League Against Epilepsy (ILAE), as modified in
- •Absence of evolving space-occupying lesions or progressive neurological diseases.
- •Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
- •All female subjects must have negative pregnancy test results
- •Subjects must weigh at least 50 kg to participate in this study and must have a body mass index (BMI) within the range of 18 to 35.
排除标准
- •A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
- •Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
- •Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
- •Having electrodes implanted in the brain.
- •Having evidence on physical examination, or a history of any medically significant thyroid, cardiac, respiratory, hepatic, gastrointestinal, renal, hematologic, oncologic, psychiatric or progressive neurological disorder, requiring current medical intervention/therapy likely to have a significant impact on the outcome of this study.
- •With any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, e.g. GI surgery and/or pancreatic or liver disease
- •Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
- •Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy
时间窗: 7 days
次要结局
- Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.(9 days)
- Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures(9 days)
- Measure:An efficacy of investing. drug vs. Pcb in reducing the seizure rate when administered orally for up to 9days (during titration monotherapy)in pts. with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy surgery.(9 days)
研究者
研究点 (1)
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