EUCTR2009-017904-95-GR进行中(未招募)不适用
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
psher-Smith Laboratories, Inc.0 个研究点目标入组 172 人开始时间: 2011年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have completed the maintenance period of the P09-004 study, unless otherwise approved by the sponsor.
- •Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- 未提供
研究者
相似试验
进行中(未招募)
不适用
uncontrolled epilepsyEUCTR2009-017904-95-DEpsher-Smith Laboratories, Inc.275
进行中(未招募)
不适用
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset SeizuresRefractory partial-onset seizures with or without secondary generalizationMedDRA version: 14.0Level: PTClassification code 10056209Term: Partial seizures with secondary generalisationSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: PTClassification code 10040703Term: Simple partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: LLTClassification code 10034090Term: Partial seizures, complexSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: LLTClassification code 10048674Term: Partial seizures with secondary generalizationSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: PTClassification code 10010145Term: Complex partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: LLTClassification code 10034091Term: Partial seizures, simpleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-017904-95-HUpsher-Smith Laboratories, Inc.172
进行中(未招募)
1 期
Clinical Trial Extension Study with Avapritinib for Patients with Gastrointestinal Stromal Tumorsocally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)MedDRA version: 21.1Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-005751-21-FRBlueprint Medicines5
进行中(未招募)
1 期
Follow on study for participants involved in the P09- 004 Study which examines if USL255 is safe in patients with refractory partial-onset seizuresEUCTR2009-017904-95-BEpsher-Smith Laboratories, Inc.275
已完成
3 期
Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onsetSeizures (a type of epilepsy of fits) who had participated in study P09-004.CTRI/2012/06/002721psherSmith Laboratories Inc172
