NCT01647880终止2 期
Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Efficacy parameters
研究概览
简要总结
In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- •ability to consent and a written approval
- •First acute ON attack to the fit eye within 30 days before screening
- •Age 18 - 55 years at screening
- •EDSS ≤ 6.0
- •No MS Attack except for ON in the last 30 days before screening
- •No immunomodulatory therapy for at least three Months (before randomization), or
- •strong immunomodulatory therapy with interferon beta or glatiramer acetate for at least 6 months
- •visus in the affected eye at least 0.1
- •latency of Conventional VEP in the affected eye
- •= 115 ms or difference> = 15 ms to the opposite side at a Study at least 4 but no more than 6 weeks after Onset of clinical symptoms
- •At least 2 T2 lesions typical of MS in a previous MRI
排除标准
- •other MS course than RRMS
- •any condition which could interfere or prevent the MRI study or other investigations
- •known allergy or intolerance, or other contraindication against Gd-DTPA
- •Patients with known contraindications to treatment with fingolimod (Gilenya ®) or interferon beta-1b Extavia ®
- •Competing diseases which could affect visual functions such as diabetic, retinopathy, glaucoma, retinal detachment
研究组 & 干预措施
Fingolimod (Gilenya®)
Experimental
0,5 mg once a day in the morning, oral
干预措施: Verum arm receiving Gilenya® (Drug)
Interferon beta-1b (Extavia®)
Active Comparator
every second day, s.c.
干预措施: Active Comparator receiving Extavia® (Drug)
结局指标
主要结局
Efficacy parameters
Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline
次要结局
- Efficacy parameters
研究者
Friedemann Paul
Sponsor Deputy
Charite University, Berlin, Germany
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)Cancer of PancreasChemotherapy EffectMetastatic Pancreatic CancerNCT04769414Menoufia University48
已完成
3 期
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes CColon Cancer Stage IIINCT00309530Austrian Breast & Colorectal Cancer Study Group598
已完成
2 期
mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic CancerMetastatic Pancreatic CancerNCT02028806Yuhong Li40
已完成
3 期
Anidulafungin In Treatment Of Candidemia In Asian SubjectsCandidemiaNCT00537329Pfizer43
Unknown
不适用
Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple SclerosisMultiple SclerosisNCT03216915Universitätsklinikum Hamburg-Eppendorf100