A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 85
- 主要终点
- Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase
研究概览
简要总结
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
- •Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
- •Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
- •Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
- •Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).
排除标准
- •Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.
- •Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
- •A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
- •Status epilepticus within 1 year prior to screening.
- •Seizures related to drugs, alcohol, or acute medical illness.
- •Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase.
- •Progressive structural CNS lesion or a progressive encephalopathy.
研究组 & 干预措施
Placebo
干预措施: Pregabalin add-on therapy (Drug)
Pregabalin Level 1 (max 150 mg/day)
干预措施: Pregabalin add-on therapy (Drug)
Pregabalin Level 2 (max 600 mg day)
干预措施: Pregabalin add-on therapy (Drug)
结局指标
主要结局
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase
时间窗: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase
时间窗: Day 1 up to Week 12
All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
次要结局
- Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase(Day 1 up to Week 12)