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临床试验/NCT00220415
NCT00220415已完成3 期

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

UCB Pharma1 个研究点 分布在 1 个国家开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
UCB Pharma
试验地点
1

研究概览

简要总结

Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in this research study at approximately 80 different locations in Australia and Europe.

The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.

Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, and completion of a seizure diary.

Patients who complete the study may enroll in an extension trial and receive active study drug.

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

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • partial seizures with or without secondary generalization

排除标准

  • subjects received SPM 927 in a previous trial

研究者

发起方
UCB Pharma
申办方类型
Industry

研究点 (1)

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