EUCTR2010-021448-17-SK进行中（未招募）不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not available
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
- •Male and female outpatients age 18 to 66 years (inclusive) with weight of = 45 Kg (99 lb);
- •Completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues;
- •Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected;
- •Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed;
- •Provided written informed consent before any extension assessment is performed.
- •Are the trial subjects under 18? no
- •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
- •History of status epilepticus or seizure clusters occurring during Study CBGG492A2207 or in the period between the end of study CBGG492A2207 and the start of study CBGG492A2212 for patients experiencing a treatment gap.
- •Patients who have been treated with:
- •Felbamate, unless treatment has been continuous for = 2 years;
- •Vigabatrin during 26 weeks prior to the first dose of open-label medication in the extension study;
- •Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of openlabel medication in the extension study;
- •L-Dopa formulations;
- •Used concomitant medication that are potential inhibitors of OATP transporters e.g.
- •cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study.
- •No physical examination changes suggestive of progressive neurological changes (e.g. Alzheimer’s disease, Parkinson’s Disease, Multiple Sclerosis) during Study CBGG492A2207;
- •History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides);
- •Pregnant or lactating females.
研究者
相似试验
进行中（未招募）
不适用
Effectiveness and safety of BGG492 as add-on treatment in patients with partial onset seizuresEpilepsy Partial onset seizuresMedDRA version: 13.1Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-021448-17-DEovartis Pharma Services AG62
进行中（未招募）
不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not availableEpilepsy Partial onset seizuresMedDRA version: 12.1Level: LLTClassification code 10065336Term: Partial epilepsyEUCTR2010-021448-17-HUovartis Pharma Services AG
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic ArthritisPsoriatic ArthritisEUCTR2017-001003-74-CZCB Biopharma SPR200
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic ArthritisMedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859Psoriatic ArthritisEUCTR2017-001003-74-DECB Biopharma SR200
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic ArthritisPsoriatic ArthritisEUCTR2017-001003-74-HUCB Biopharma SPR200