NCT01262677已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.81 个研究点 分布在 9 个国家目标入组 325 人开始时间: 2011年2月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 81
- 主要终点
- Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
研究概览
简要总结
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
- •Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs
排除标准
- •Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
- •Status epilepticus within one year prior to screening
研究组 & 干预措施
pregabalin CR 330 mg
Experimental
干预措施: pregabalin (Drug)
pregabalin CR 165 mg
Experimental
干预措施: pregabalin (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
时间窗: Week 0 to Week 14
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
次要结局
- Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase(Week 0 to Week 14)
- Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase(Week 0 to Week 14)
- Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase(Week 0 to Week 14)
- Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase(Week 2 to Week 14)
- Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase(Week 0 to Week 14)
- Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase(Week 2 to Week 14)
- Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14(Baseline, Week 14)
- Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14(Baseline, Week 14)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Snoring Score at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14(Baseline, Week 14)
- Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14(Baseline, Week 14)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14(Baseline, Week 14)
- Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale(Week 14)
- Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question(Week 14)
- BSW: Satisfaction From Treatment Question(Week 14)
- BSW: Willingness to Continue Question(Week 14)
- Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase(Day 1 to Week 15)
- Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase(Day 1 to Week 15)
- Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)(Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase))
- Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase(Day 1 to Week 15)
- Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms(Week 15)
- Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase(Week 15)
- Percentage of Participants With Laboratory Test Abnormalities During the Study(Day 1 to Week 15)
研究者
研究点 (81)
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