CTRI/2023/11/060096尚未招募2 期
Evaluation of efficacy of adjunctive oral perampanel in children with Lennox Gastaut syndrome: a double-blind, placebo-controlled randomized trial - NI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •1.Participants must have a diagnosis of LGS as evidenced by: more than one type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1; an electroencephalogram (EEG) reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike, and wave pattern <2.5 hertz [Hz]).
- •2.Aged 4-18 years Participants must have experienced an average of at least 2 drop seizures per week in the 4-week
- •3.Baseline Period preceding randomization: Participants must have been receiving 1 to 4 concomitant antiepileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1
排除标准
- •1. Prior treatment with perampanel within 30 days of visit 1
研究者
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