A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group
研究概览
简要总结
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
- •A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).
排除标准
- •A document history of generalized status epileptics in the past 6 months.
- •Seizures having a metabolic, neoplastic, or active infectious origin.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TRI476
Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
干预措施: TRI476 (Drug)
TRI476
Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
干预措施: Benzodiazepines (Drug)
Placebo
Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
干预措施: Placebo to TRI476 (Drug)
Placebo
Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
干预措施: Benzodiazepines (Drug)
结局指标
主要结局
Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group
时间窗: screening and 28 days
Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.
次要结局
- Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group(baseline, 28 days and 56 days)
- Percent of Participants With Response During Double-blind Phase, by Treatment Group(screening to 28 days)
- Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type(28 days)
- Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group(56 days)