Short term efficacy of adjunctive prednisolone in children with Lennox Gastaut syndrome aged 3-12 years: A parallel design, randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy
研究概览
简要总结
Lennox Gastaut Syndrome (LGS) is a unique childhood onset epileptic encephalopathy which is often drug refractory. No consensus exists on the management of LGS in children. Non pharmacological therapies such as ketogenic diet, neuromodulation with vagal nerve stimulation and epilepsy surgery have major limitations and may not suit all. Recent studies suggest a role of neuroinflammation in the pathogenesis of LGS. Oral steroid therapy has been found to be useful in other epileptic encephalopathies associated with neuroinflammation such as Developmental and epileptic encephalopathy with spike-wave activation in sleep (D/EE-SWAS) and Infantile epileptic spasm syndrome (IESS). Small case series show that steroid therapy may be useful in reducing seizure frequency and improving neurocognitive outcome in LGS. Hence there is need for prospective studies and RCTs to analyze the efficacy of steroids on seizure frequency, EEG response and neurobehavioral outcome in LGS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with LGS as per ILAE 2017 definition with Age 3-12 years Have failed at least 4 ASMs with adequate dose and duration Experiences more than four seizures per month with at least 1 seizure per week On a stable antiseizure drug regime On a stable ketogenic diet ratio, if diet is ongoing.
排除标准
- •Primary Exclusion Criteria 1.Has a diagnosed progressive neurodegenerative or neurometabolic disorder 2.Has history of recurrent infections (one per month) requiring hospitalization in the past three months before enrollment.
- •3.Had a history of febrile illness within last 15 days before enrollment 4.Is a candidate for epilepsy surgery and parents willing to undergo the same.
- •5.Has received steroids in the past for more than two weeks as treatment for LGS 6.Is on treatment for any other (already diagnosed) chronic health condition which may worsen with steroid therapy.
- •Secondary exclusion criteria To be applied after the four week observation phase 1.Occurrence of any febrile illness lasting more than 24 hours 2.Change in ASMs (use of abortive therapy with benzodiazepine is allowed) 3.Chest X-ray or Mantoux test suggestive of Tuberculosis 4.Seizure frequency less than 1 seizure per week.
结局指标
主要结局
1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy
时间窗: 1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy
次要结局
- 1.To compare the proportion of children with LGS who develop more than 5 point improvement in T-score in any behavioral domain of Childhood behavior checklist (CBCL) between intervention arm (oral prednisolone + ASMs) and control arm (Standard ASMs alone) at 12 weeks (7 days) of therapy.(2.To compare the mean change in PINACLE score from baseline at 12 weeks (7 days) of therapy between intervention arm and control arm.)
研究者
Dr Prashant Jauhari
AIIMS New Delhi