NCT00203099已完成2 期
A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
研究概览
简要总结
This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically Definite Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983).
- •Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans.
- •Subjects must have a relapsing-remitting disease course.
- •Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10).
- •Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
- •Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide).
- •Subjects must be between the ages of 18 and 50 years inclusive.
- •Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
- •Subjects must be willing and able to give written informed consent prior to entering the study.
排除标准
- •Previous use of injected glatiramer acetate.
- •Previous use of cladribine within 2 years prior to screening visit (week -10).
- •Previous use of immunosuppressive agents in the last 6 months.
- •Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry.
- •Use of interferon agents within 60 days prior to the screening visit.
- •Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
- •Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit.
- •Previous total body irradiation or total lymphoid irradiation (TLI).
- •Pregnancy or breastfeeding.
- •Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
- •A known history of uncontrolled asthma.
- •A known history of sensitivity to mannitol or acetylcysteine.
- •Inability to successfully undergo MRI scanning.
研究组 & 干预措施
Glatiramer Acetate, N-Acetylcysteine
Active Comparator
干预措施: Glatiramer Acetate, N-Acetylcysteine (Drug)
结局指标
主要结局
Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
时间窗: 46 weeks
Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 \[screening\], -6 and 0 \[baseline\]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 \[termination\]).
次要结局
- MRI parameters(46 Weeks)
研究者
相似试验
已完成
3 期
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.dType 2 Diabetes MellitusNCT01787396LG Life Sciences433
已完成
2 期
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With PresbyopiaPresbyopiaNCT02780115Allergan151
Unknown
3 期
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML PatientsInduction ChemotherapyAcute Myeloid LeukemiaNCT04087967The First Affiliated Hospital of Soochow University162
Unknown
3 期
Study to Evaluate the Efficacy and Safety in Patients With Primary HypercholesterolemiaPrimary HypercholesterolemiaNCT05206578Ahn-Gook Pharmaceuticals Co.,Ltd264
已完成
1 期
Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients.Glycogen Storage Disease Type II (GSD II)Acid Maltase DeficiencyPompe DiseaseNCT01898364Genzyme, a Sanofi Company24