CTRI/2009/091/000668已完成3 期
A Multicenter, Randomized Open-Label, Comparative, ProspectiveClinical Trial to Investigate Efficacy and Safety of Lacosamide versusLevetiracetam as an Adjunctive Treatment in Patients With RefractoryEpilepsy Suffering From Partial Onset Seizures With or WithoutSecondary Generalization.
Torrent Pharmaceuticals Ltd0 个研究点目标入组 216 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female patients between 17 and 70 years of age (both inclusive) with confirmed refractory epilepsy suffering from partial onset seizures with or without secondary generalization and maintaining a stable dose regimen of at least one Anti-epileptic drug (AED) for one month before screening
- •2. Documented history of patients with minimum 2 seizures in past two months, with at least 1 seizure in last one month.
排除标准
- •1. Patients unable/unwilling to give informed written consent
- •2. Patients with seizures occurring in clusters
- •3. Patients with Status Epilepticus within 3 months of enrollment
- •4. Patients with history of non-epileptic seizures
- •5. Patients with known allergic reaction or intolerance to study drugs and /or
- •6. Patients with liver enzymes more than 2.5X the normal value and/or bilirubin
- •more than 1.5X the normal value and/or serum creatinine more than the upper
- •limit of the normal value
- •7. Patients with progressive neurological disorders like multiple sclerosis,
- •Guillain-Barre syndrome
- •8. Presence of significant cardiac dysfunction or clinically important ECG
- •abnormalities
- •9. Patients with serious psychiatric disorders like Schizophrenia, Bipolar disorder
- •with suicidal tendencies
- •10. Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics
- •within 28 days prior to screening
- •11. Patients who have participated in any other investigational drug trial within
- •the four weeks preceding study entry
- •12. Women patient of childbearing potential, not practicing medically acceptable
- •(non-hormonal) method of contraception
- •13. Pregnant or lactating women, children and adolescents below 17 years
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