NL-OMON34560已完成3 期
An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset Seizures (RGB113905) - RGB113905
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age 18 years and above (men or women).
- •* Epilepsy with partial-onset seizures i.e., simple or complex partial seizures with or without secondary generalization (International League Against Epilepsy (ILAE) classification; 1981) for more than 24 weeks prior to the Baseline Visit.
- •* At least 4 partial-onset seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week prospective Baseline Phase with at least one partial seizure occurring during each 4-week period.
- •* Is currently receiving a stable dose of one of the following AEDs: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam or valproic acid in a stable dose for 4 weeks prior to Baseline Visit (retrospective or prospective) and during the Baseline period. Benzodiazepines used in any manner other than acute usage as defined in this protocol will be considered concurrent AED usage and will not be permitted.
- •* Adequate contraception for females of childbearing potential.
排除标准
- •* History of generalised epilepsy.
- •* Status epilepticus (other than simple partial status epilepticus) within the 24 weeks prior to Baseline Visit.
- •* Participation in a previous retigabine study (subjects with documented evidence of having received placebo will be eligible).
- •* Is currently following or planning to follow the ketogenic diet.
- •* Has been treated with vigabatrin within the past 6 months prior to Baseline; if a subject has been previously treated with vigabatrin, a visual perimetry test after discontinuation of vigabatrin must show no visual field constriction.
- •* Active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- •* Pregnancy or lactation.
研究者
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The purpose of this study is to test the safety of retigabine, the study drug, and how well it works at different doses when taken with other antiepileptic drugs (AEDs). We want to find out what effects, good or bad, it has on people with epileptic seizures.This study will look at how well retigabine works when added to certain other individual antiepileptic medications. The study medication will be increased at a slower rate and at different doses than used in previous studies.Epilepsy - partial-onset seizures with or without secondary generalisationMedDRA version: 14.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-017744-14-PLGlaxoSmithKline Research and Development Ltd205
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