EUCTR2013-003420-37-PT进行中（未招募）1 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 1 MONTH THROUGH <4 YEARS OF AGE WITH PARTIAL ONSET SEIZURES - Pregabalin, Phase 3 Study in children < 4 years of age with partial onset seizures
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 175 人开始时间: 2014年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
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
- •- Subject must have 3 partial onset seizures in the month prior to screening.
- •- Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- •- Signed Informed Consent
- •- On 1-3 stable anti-eplieptic drugs at screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 123
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms
- •- Lennox-Gasteau, BECTS, and Dravet's syndrome
- •- Status epliepticus within 1 year of screening
- •- Any change in AED regimen with 7 days of screening
- •- Progressive structural central nervous system (CNS) lesion or a progressive encepholopathy
- •- Progressive errors of metabolism
研究者
相似试验
已完成
3 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURESEpilepsy with partial onset seizures10039911NL-OMON39878Pfizer3
进行中（未招募）
1 期
A safety and efficacy study of pregabalin in children 4-16 years of age for partial onset seizuresPartial onset seizuresMedDRA version: 14.1Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-020852-79-GRPfizer Inc.235 East 42nd Street, New York, NY 10017225
进行中（未招募）
1 期
A safety and efficacy study of pregabalin in children 4-16 years of age for partial onset seizuresEUCTR2010-020852-79-EEPfizer Inc.235 East 42nd Street, New York, NY 10017295
进行中（未招募）
1 期
A safety and efficacy study of pregabalin in children 4-16 years of age for partial onset seizuresPartial onset seizuresMedDRA version: 14.0Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-020852-79-FRPfizer Inc.235 East 42nd Street, New York, NY 10017153
进行中（未招募）
1 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF THE MGLUR5 NEGATIVE ALLOSTERIC MODULATOR ADX10059 IN THE ACUTE TREATMENT OF MIGRAINEMigraine with or without auraMedDRA version: 8.1Level: PTClassification code 10027599EUCTR2006-001488-51-DEAddex Pharmaceuticals S.A.150