EUCTR2007-005440-25-ES进行中（未招募）1 期
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures Ensayo de extension abierto multicentrico para evaluar el uso a largo plazo de la monoterapia con lacosamida y la seguridad de la momoterapia y el tratamiento complementario con lacosamida en pacientes con crisis parciales
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 322
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
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject has entered the Maintenance Phase of the double-blind trial, SP902 (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902.
- •3. Subject is expected to benefit from participation in an open-label extension trial with LCM, in the opinion of the investigator.
- •4. Subject is willing and able to comply with all trial requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
- •2. Subject meets the withdrawal criteria (excluding exit criteria) for the previous trial (SP902) or is experiencing an ongoing serious adverse event (SAE).
研究者
相似试验
进行中（未招募）
1 期
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset SeizuresEUCTR2007-005440-25-FRSCHWARZ BIOSCIENCES, Inc.322
进行中（未招募）
不适用
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset SeizuresEUCTR2007-005440-25-ATSCHWARZ BIOSCIENCES, Inc.225
进行中（未招募）
不适用
A continuation study to assess long term safety of Lacosamide (approved drug in Europe) monotherapy and safety of Lacosamide monotherapy and Adjuctive therapy in people with partial-onset seizuresPartial-onset seizures (with and without secondary generalization)MedDRA version: 14.1Level: PTClassification code 10010145Term: Complex partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: PTClassification code 10040703Term: Simple partial seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-005440-25-Outside-EU/EEACB BIOSCIENCES, Inc.294
进行中（未招募）
不适用
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset SeizuresPartial Epilepsies Partial Onset SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004384-21-Outside-EU/EEACB BIOSCIENCES, Inc.100
进行中（未招募）
1 期
A continuation study to assess long term safety of Lacosamide (approved drug in Europe) monotherapy and safety of Lacosamide monotherapyand Adjuctive therapy in people with partial-onset seizuresPartial-onset seizures (with and without secondary generalization)MedDRA version: 17.0Level: PTClassification code 10010145Term: Complex partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 17.0Level: PTClassification code 10040703Term: Simple partial seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-005440-25-DKCB BIOSCIENCES, Inc.294