Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,498
- 主要终点
- Responder Rate
研究概览
简要总结
There are a number of anti-epileptic drugs available for the treatment of partial onset seizures in patients with epilepsy. This study is a systematic review of the published literature on anti-epileptic drugs and is designed to compare the relative effectiveness and tolerability of a selection of them with retigabine. The drugs chosen for this comparison were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen because they belong to the newer generation of drugs for epilepsy (as does retigabine) and they have a similar license as well as having published data from studies that were conducted in similar patient populations with similar methods. GSK commissioned YHEC (York Health Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies from international databases. These studies had compared one of the chosen anti-epileptic drugs with placebo. The results were pooled and combined in order to summarize the data for individual drugs as well to compare the results for different drugs with each other and with retigabine. Since none of the individual clinical studies compared one active drug with another, this systematic review is an indirect comparison of these drugs, using an established and recognised methodology which has well understood limitations.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have participated to a study that meets the following criteria:
- •Be a study of retigabine, eslicarbazepine, lacosamide, zonisamide, pregabalin or tiagabine as an adjuvant therapy, compared to placebo or another drug;
- •Be a randomized, placebo-controlled, add-on trial, or a parallel trial or cross-over trial in which data from the first treatment period could be treated as a parallel study;
- •Have recruited patients with drug-resistant partial epilepsy (i.e., simple partial, complex partial, and/or secondarily generalised tonic-clonic seizures not controlled by at least 1 or more other AEDs);
- •Have a maintenance treatment period of 8 weeks or longer, with a prospective baseline of minimum 4 weeks.
排除标准
- 未提供
研究组 & 干预措施
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
干预措施: retigabine/ezogabine (Drug)
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
干预措施: lacosamide (Drug)
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
干预措施: zonisamide (Drug)
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
干预措施: pregabalin (Drug)
Drug-resistant (or refractory) partial epilepsy of all types
Drug-resistant (or refractory) partial epilepsy of all types
干预措施: eslicarbazepine (Drug)
结局指标
主要结局
Responder Rate
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)
Median Seizure reduction
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Median percent reduction in seizure frequency from baseline
Seizure severity
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Seizure severity (any definitions acceptable)
Time to onset of treatment effect
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Time to onset of treatment effect
Seizure free patients
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Proportion of patients who are seizure free (and time period over which this was measured)
Changes in HRQoL
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Changes in HRQoL
Drop outs due to AE
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Proportion of patients who drop out of the studies (as a result of adverse events i.e. tolerability)
All drop outs
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Proportion of patients who drop out of the studies for any reason
Adverse events
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Percentage of patients reporting 5 key adverse events identified by the Cochrane Epilepsy Group as common and important adverse effects of antiepileptic drugs: ataxia, dizziness, fatigue, nausea or somnolence
Mortality
时间窗: Duration of studies included in the systematic review up to 28 weeks of double blind period
Mortality
次要结局
未报告次要终点