A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 122
- 主要终点
- Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
研究概览
简要总结
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seizures classified as Primary Generalized Tonic Clonic Seizures
- •Must have at least 1 PGTC seizure in the 8 weeks prior to screening
- •Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
- •Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
- •Signed informed consent and assent if a minor
- •Ability to comply with daily seizure and dosing diary requirements and all study procedures
排除标准
- •A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
- •Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
- •Status Epilepticus within 1 year prior to screening
- •Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
- •Seizures related to drugs, alcohol, or acute medical illness
- •Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
- •Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
- •Progressive inborn errors of metabolism.
研究组 & 干预措施
Study Drug Level 1
干预措施: Pregabalin Dose Level 1 (Drug)
Study Drug Level 2
干预措施: Pregabalin Dose Level 2 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
时间窗: Day 1 up to Week 12
All PGTC 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 PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*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 Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase(Day 1 up to Week 12)