NCT00143130
已完成
3 期
Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
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 227 人2005年4月
概览
- 阶段
- 3 期
- 干预措施
- Pregabalin
- 疾病 / 适应症
- Seizures
- 发起方
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Reduction in seizure frequency.
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.
研究者
入排标准
入选标准
- •met the inclusion/exclusion criteria for A0081005
- •have completed the 21-week study and have shown a significant clinical response and wish to continue treatment
排除标准
- •Having a treatable cause of seizure.
- •Having a progressive neurological or systemic disorder
研究组 & 干预措施
Single Arm
干预措施: Pregabalin
结局指标
主要结局
Reduction in seizure frequency.
时间窗: 18 months
次要结局
- Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).(18 Months)
- Seizure-free patients during each 3-month period(18 Months)
- Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).(18 Months)
研究点 (1)
Loading locations...
相似试验
终止
4 期
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy TrialPartial SeizuresNCT00407797Pfizer's Upjohn has merged with Mylan to form Viatris Inc.136
已完成
4 期
Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.SeizuresNCT00141427Pfizer's Upjohn has merged with Mylan to form Viatris Inc.540
已完成
3 期
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.Seizure Disorder, PartialNCT00141245Pfizer325
已完成
3 期
Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.Seizure Disorder, PartialNCT00150293Pfizer337
已完成
3 期
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial SeizuresSeizure Disorder, PartialNCT00141388Pfizer455