NCT00537238已完成3 期
A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2007年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Response to Treatment
研究概览
简要总结
This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.
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
- •Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
- •Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
- •Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
排除标准
- •Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
- •Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
研究组 & 干预措施
B
Active Comparator
干预措施: pregabalin (Drug)
A
Active Comparator
干预措施: levetiracetam (Drug)
结局指标
主要结局
Proportion of Participants With Response to Treatment
时间窗: Baseline up to Week 16
Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.
次要结局
- Medical Outcomes Study Sleep Scale (MOS-SS) Score(Baseline, Week 16)
- Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score(Baseline, Week 16)
- Percent Change From Baseline in 28 Day Seizure Frequency at Week 16(Baseline, Week 16)
- Percentage of Participants Without Seizures(Baseline up to Week 16)
- Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16(Baseline, Week 16)
- Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up(Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase))
- Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Week 16)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.Partial Onset SeizuresNCT02072824Pfizer's Upjohn has merged with Mylan to form Viatris Inc.175
已完成
4 期
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial SeizuresPartial Seizure DisorderEpilepsies, PartialComplex Partial Seizure DisorderEpilepsyNCT00537940Pfizer's Upjohn has merged with Mylan to form Viatris Inc.482
已完成
2 期
Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & SleepPeripheral NeuropathiesDiabetes MellitusNCT00370656University of Surrey90
终止
1 期
A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisArthritis, RheumatoidRheumatoid ArthritisNCT03161457JHL Biotech, Inc.153
已完成
3 期
Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From EpilepsyGeneralized EpilepsyNCT00150735UCB Pharma580