A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
研究概览
简要总结
This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.
详细描述
After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy with partial seizures.
- •Males or females, age 18 years or older.
- •Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
- •Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.
排除标准
- •Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
- •Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
- •Primary generalized epilepsy or status epilepticus within the previous year.
研究组 & 干预措施
1
干预措施: pregabalin 600 mg/day (Drug)
2
干预措施: pregabalin 150 mg/day (Drug)
结局指标
主要结局
Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
时间窗: Week 2 up to Week 18
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (\>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP \>2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier \[KM\] product limit estimate for survival function) \* 100%
次要结局
- Percentage of Participants Completing 20 Weeks of Double-Blind Treatment(Randomization up to Week 20)
- Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria(Week 2 up to Week 18)
- Percentage of Participants Who Met Protocol-Specified Exit Events(Week 2 up to Week 18)
- Mean Time on Pregabalin Monotherapy(Week 2 to Week 20)
- Percentage of Seizure-Free Participants by Study Phase(Day 1 up to Day 140)
- Pregabalin Population Pharmacokinetics (PK)(Baseline up to 20 weeks)
- Pregabalin Exposure-Response Analysis(Day 126)