NCT01191086已完成3 期
Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
研究概览
简要总结
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed the maintenance period of the P09-004 study.
- •Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
排除标准
- 未提供
研究组 & 干预措施
Open-label USL255
Experimental
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
干预措施: USL255 (Drug)
结局指标
主要结局
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
时间窗: Open label treatment of up to 62 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset SeizuresEpilepsyNCT01142193Upsher-Smith Laboratories249
已完成
1 期
A Study of LY2439821 in Rheumatoid ArthritisRheumatoid ArthritisNCT01236118Eli Lilly and Company28
已完成
3 期
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic MedicationSchizophreniaNCT05741528Otsuka Pharmaceutical Development & Commercialization, Inc.75
已完成
3 期
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With HypertensionHypertensionNCT00457626Novartis Pharmaceuticals66
终止
3 期
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaNCT04596995UCB Biopharma SRL43