A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 60
- 主要终点
- Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
研究概览
简要总结
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization.
Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.
Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.
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
- •Subject with partial seizures with or without secondary generalization
排除标准
- •Subject had previously received iv SPM 927
- •Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.
研究组 & 干预措施
1
干预措施: iv SPM 927 and oral placebo tablet (Drug)
2
干预措施: oral SPM 927 tablet and iv placebo (Drug)
3
干预措施: iv SPM 927 and oral placebo tablet (Drug)
4
干预措施: oral SPM 927 tablet and iv placebo (Drug)
结局指标
主要结局
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
时间窗: 2 Days
次要结局
- Seizure counts(2 days)