Meta-Analysis of VRX-RET-E22-303 and VRX-RET-E22-304: Two Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Studies of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extensions of Studies VRX-RET-E22-301 and VRX-RET-E22-302)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing open-label extension (OLE) Studies VRX-RET-E22-303 and VRX-RET-E22-304.
详细描述
Data from the October 2009 data-cut of ongoing Studies VRX-RET-E22-303 (Study 303) and VRX-RET-E22-304 (Study 304) will be pooled, summarized, and published with the goal of providing updated long-term safety and efficacy information for subjects and prescribers following the recent positive CHMP opinion for retigabine for adjunctive use in patients with partial seizures. Studies 303 and 304 are the open-label extensions of two Phase 3 studies (VRX-RET-E22-301 and VRX-RET-E22-302), respectively. Studies 301 and 302 were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg per day (Study 302) and 1200 mg per day (Study 301). All subjects who wished to enter the OLE studies and, in the opinion of the investigator, were expected to benefit from participation in the OLEs, entered a 6-week (Study 301) or 4-week (Study 302) transition phase in which their dose of retigabine was titrated to or maintained at 400 mg TID (Study 301) or 300 mg TID (Study 302). Upon completion of the Transition phase, subjects enrolled into the extension studies. Once enrolled in the OLE, doses could be adjusted within the range of 600 mg to 1200 mg per day. Treatment in Studies 303 and 304 is planned to continue until regulatory approval and commercialization of retigabine or until the program is discontinued.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
retigabine/ezogabine
retigabine/ezogabine; dose range up to 1200 mg/day
干预措施: retigabine/ezogabine (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: during open-label drug exposure up to database cutoff (max 40 months)
Adverse events were the primary means to assess safety.
次要结局
- Time to Discontinuation(during open-label extension up to date of discontinuation; subjects who continue in the study are censored at database cutoff (max 40 months))
- The number and percent of subjects exposed to study drug(for at least 3, 6, 12, 18, 24 and 32 months)
- Listing of abnormal liver function test results and liver adverse events(during open-label drug exposure up to database cutoff (max 40 months))
- Observed values and change from baseline summaries for American Urological Association symptom index scores, Post-Void Residual bladder ultrasound, Vital Signs and Weight(baseline (parent study) and at 1, 3, 12, 24 and 36 months)
- Percent change from baseline in seizure frequency(entire open-label extension period up to database cutoff (max 40 months))
- Number and percent of responders(entire open-label extension period up to database cutoff (max 40 months))
- Number and percent of seizure free subjects(during open-label drug exposure up to database cutoff (max 40 months))
- Proportion of subjects retained in the study(at 3, 6, 12, 24 and 32 months after exposure to first dose in open-label extension study.)
- Mean of average dose(entire open-label drug extension period up to database cutoff (max 40 months))