Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
- 主要终点
- PCH(T), ITT
研究概览
简要总结
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
详细描述
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Capable of complying with the study procedures.
- •Able to provide written informed consent
- •Male or female aged 18 to 65 years, inclusive.
- •Diagnosis of partial onset seizures
- •Minimum of three seizures per 28 days
- •Receiving treatment with 1-3 AEDs
- •Refractory to at least one AED
- •No progressive neurological conditions by recent MRI/CT
- •Adequate birth control in women of child-bearing potential
排除标准
- •Refractory to OXC for reasons of efficacy
- •Recent status epilepticus
- •Recent non-epileptic seizures
- •Current diagnosis of major depression
- •Recent suicidal plan or intent or more than one attempt
- •Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines
- •Current use of sodium-lowering non-seizure medications.
- •Clinically significant hepatic, renal, or cardiovascular function
- •History of recent substance abuse
- •Females who are pregnant or lactating.
- •Hypersensitivity to OXC or related drugs
- •Difficulty swallowing study medication
研究组 & 干预措施
Placebo
Placebo - four identical tablets taken orally once daily
干预措施: Placebo (Drug)
2400 mg SPN-804
2400mg OXC XR taken orally once daily as four identical tablets
干预措施: 2400mg SPN-804 (Drug)
1200mg SPN-804
1200mg OXC XR taken orally once daily as four identical tablets
干预措施: 1200mg SPN-804 (Drug)
结局指标
主要结局
PCH(T), ITT
时间窗: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\[T\]), Intent-to-Treat population.
次要结局
- PCH(M)- ITT(Change at 12 weeks (Maintenance Period) compared to Baseline)
- Responder Rate, ITT(At the end of 16 weeks (4 wks Titration + 12 wks Maintenance))
- Seizure-Free Rates, ITT(At the end of 16 weeks (4 wks Titration + 12 wks Maintenance))
- Seizure Free Rate, ITT, (M)(At the end of 12 weeks (Maintenance Period))