Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- number of MRI contrast enhancing lesions
研究概览
简要总结
A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 - 55 years old
- •MS diagnosis according McDonald criteria
- •Relapsing-remitting MS
- •EDSS 0 - 6
- •Disease activity as occurrence of CEL in brain MRI
- •IFN-beta therapy for at least 6 months
排除标准
- •Primary chronic progressive MS
- •Symptoms and signs of clinical disease conditions similar to MS
- •Conditions that can disturb MRI measurements
- •Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
- •Clinically relevant lung, heart, CNS, infectious disease
- •Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
- •Allergies towards Gd-DTPA
- •Allergies towards constituents of the therapeutic agent
- •Recruitment to other clinical trials within 6 months prior to or during this study
- •Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
- •Alcohol or drug abuse
- •Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
- •Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
研究组 & 干预措施
interferon
干预措施: interferon beta treatment to add-on atorvastatin treatment (Drug)
untreated
干预措施: untreated to atorvastatin treatment (Drug)
结局指标
主要结局
number of MRI contrast enhancing lesions
时间窗: treatment months 6 to 9 compared to baseline
次要结局
- other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)(treatment months 6 to 9 compared to baseline)